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Regulatory Compliance for the Dental Laboratory – Safelink Consulting
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OSHA Compliance for the Dental Laboratory

FDA Compliance for the Dental Laboratory

DAMAS Certification or DAMAS Recertification

Dental laboratories take pride in providing the highest quality for their customers and ideal work environment for their team. Their good standing and accountability are worth protecting. For over 30 years SafeLink Consulting has been assisting dental laboratories with regulatory compliance. SafeLink Consulting offers the most comprehensive compliance programs available so the dental lab can be free to do what they do best.
SafeLink Consulting assists dental laboratories all over the U.S. with regulatory compliance and internationally with FDA compliance. Attempting to setup and maintain a customized Safety Program and/or Quality Management System on your own can cost your business a lot of valuable time and money. Eliminate unnecessary costs, headaches and frustration by contracting SafeLink to assist in establishing and managing these compliance programs. Gain peace of mind knowing that your business has reliable, customized programs in place that not only helps you protect your workers, increase your bottom line, and provide continuous improvement, but also meets the federal and/or state OSHA safety regulations and FDA Quality System requirements.
Learn more about Dental Compliance – Preventing Unnecessary Liabilities.

a. How do you know if your business has a proper infectious disease plan?
b. Does your health & safety program meet OSHA requirements & CDC guidelines and is it
communicated properly to your employees?

OSHA Compliance for the Dental Laboratory

Each year most businesses inspected by OSHA fail to meet the required standards.  Dental laboratories can be reported anonymously by an employee to OSHA, by various others such as business neighbors, or referrals which could be another regulatory agency. Even the best policies and procedures (protocols) need to be assessed annually to ensure your laboratory is compliant.

Why is assessing OSHA compliance so vital?

Assessing your business is the only way to know if you are providing a safe environment for your employees. Learn more about safety assessments.

How often do I need to train my employees?

Training requirements vary according to federal and state regulations. Learn more about safety training requirements.

What OSHA training is required for my dental lab employees?

  • Bloodborne Pathogens/Exposure Control, Chemical Safety/Hazard Communication, Personal Protective Equipment requirements, Injury and Illness Recordkeeping, Emergency Planning, Workplace Violence, Equipment Safety & Maintenance, Infection Control Practices, Job Safety Analysis, Electrical Safety & Lockout / Tagout, Hearing Protection, Walking & Working Surface Safety, Vehicle Operator’s Safety, plus, other applicable federal or state right to know plans
Learn more FAQ’s about dental lab health & safety / OSHA compliance.

What You Need to Know:

  • OSHA regulates dental laboratories (some exemptions apply).
  • An effective safety program helps you reduce worker’s comp claims.
  • OSHA has the right to conduct a random inspection – just show up!
  • The most frequently cited standards for dentistry are Hazard Communication Standard, Bloodborne Pathogen Standard, Emergency Preparedness, Respiratory Protection, Lockout/Tagout.
  • OSHA requires written documentation of your safety program.
  • Your safety program must be evaluated for its effectiveness.
  • Dental labs are subject to OSHA recordkeeping rules.

How SafeLink Consulting can assist your dental lab with OSHA compliance:

  • Onsite or Virtual Employee Safety Compliance Training – SafeLink’s safety consultants train your team in a manner that ensures knowledge retention, brings positive results, and creates better acceptance by employees. Training is customized to your dental lab’s policies and procedures. Continuing education credit also provided.
  • Onsite Safety Assessment – This assessment is proven to be the most effective method of determining your risk position regarding employee safety. An expert knowledgeable about the dental environment conducts a thorough onsite assessment of your facility and work practices providing a detailed written report of your prevention needs.
  • Due Diligence – Get a third-party evaluation of legal requirements regarding OSHA, FDA and other applicable state, federal and international requirements being met for a business you may be purchasing or selling.
  • Health & Safety Manual – This manual is customized for your dental lab to meet OSHA’s federal and/or state written requirements and is available in multiple formats: Secure Cloud-based, Electronic, or Hard Copy.
  • Safety Consulting – SafeLink’s consultant can help in developing your safety program, training employees or to give an objective outsider’s viewpoint of your existing program.
  • Online Safety Training Courses –Dental lab-specific educational courses can be utilized for new hires and current staff. Optional quiz and certificate of completion with CE credit provided.
  • Safety Connection This subscription assists with your existing health & safety program, an OSHA inspection/response if needed, or other safety issues. Includes consulting when needed, OSHA assistance, online educational training courses, and safety news pertinent to your business.
  • SDS Management – This service allows your business to receive 24/7 retrieval of Safety Data Sheet information in the event of an emergency. It also provides convenient access from your mobile device for remote workers. Safety Data Sheet information assists your business in meeting OSHA’s Hazard Communication Standards and keeping in line with the Globally Harmonized System. SafeLink’s electronic access option eliminates the need for paper copies of Safety Data Sheets.

FDA Compliance for the Dental Laboratory

The U.S. Food and Drug Administration (FDA) regulates dental laboratories. FDA has a right to inspect dental labs. If your dental lab meets the criteria in the FDA Title 21 requirement, then your business must comply with this requirement.

FDA’s Title 21 requirement

Domestic or foreign manufacturers of medical devices are required by FDA to have “a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.  The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with GMP requirements in the QS regulation.”

Who must register with FDA?

There are many activities performed by dental laboratories that trigger registration with FDA. A SafeLink consultant can help you with making this determination.

What You Need to Know about Dental Laboratory FDA Compliance:

  • FDA regulates dental laboratories
  • Dental labs that outsource to foreign labs must register with FDA
  • FDA has a right to inspect all dental labs
  • All dental labs should have a documented quality system
  • CAPA (Corrective Action) is required and helps you reduce remakes
  • If you manufacture sleep apnea devices or anti-snoring devices, then you must register with FDA
  • A contract manufacturer must register and pay an annual fee to FDA
  • You must formally evaluate your vendors and subcontractors for compliance to regulatory requirements
  • You must be able to trace your patient contact materials in the event of recall
  • You must conduct an internal audit of your quality system at least annually
  • You must document all complaints from dental clients
  • You must implement an effective corrective action process for complaints
  • You must comply with FDA to become DAMAS certified
Learn more FAQ’s about dental lab quality systems / FDA compliance.

Quality Management Systems (QMS)

Whether your business needs a fundamental Quality Management System to meet FDA compliance or desires a more comprehensive QMS to improve your overall business model, SafeLink Consulting is ready to help. Hiring SafeLink to assist your business is the most beneficial method of developing your Quality Management System. Benefits of a Dental Lab Quality System & DAMAS Certification: https://info.safelinkconsulting.com/blog/dental_lab_quality_management_system_certification

How SafeLink Consulting can assist your dental lab with FDA compliance:

  • Product-Focused QMS Developing a Quality System for a certain product you are manufacturing? This Product-Focused Quality Management System (QMS) is designed to assist you in development of a Quality System that follows FDA’s Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation and any other FDA regulations applicable to your desired scope. Includes: onsite or virtual consulting, electronic Quality System documentation, assistance with FDA communication, educational online training courses, quality topic news relevant to the dental lab, and an onsite internal audit.
  • All-Encompassing QMS Exploring more ways to improve your business? This Quality Management System (QMS) is designed for the lab that desires an extensive QMS which goes beyond simply FDA compliance. The goal of this QMS is to improve your overall business model for productivity, efficiency and profitability by minimizing errors. A well-structured quality system provides methods for determining the root cause of complaints and reducing reworks/remakes. Ultimately, it will improve your business. This QMS also follows FDA’s Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation and any other FDA regulations applicable to your business model. Includes: onsite or virtual consulting, electronic Quality System documentation, assistance with FDA communication, educational online training courses, quality topic news relevant to the dental lab, and onsite internal audit.
  • UQ System: Cloud-based Quality Manual This Cloud-based application is designed for implementing and managing a quality system online. It reduces paper and the likelihood of a lost quality manual. UQ offers better organization of all documents, plus links policies, procedures and forms. It increases efficiency and provides an audit trail, simplifying a potentially complex issue. UQ allows for tracking non-conformance to improve quality. It can also manage your health & safety manual.
  • DIY Quality System for the Dental Lab This Do-It-Yourself is an affordable way for the dental lab to develop its own Quality System to comply with FDA’s Quality System/Good Manufacturing Practices requirements. Customizing and printing your own dental lab-specific Quality Manual is simple with easy-to-follow instructions, evaluation tools, sample forms, and standard operating procedures. This DIY is easy to use, self-directed and self-paced. It is sent in a downloadable, electronic/softcopy format.
  • Quality System Internal Audit Need an Internal Audit to meet the FDA requirements? SafeLink can perform this audit for you to establish conformance with the FDA Quality System Regulation. FDA requires that establishments periodically perform an Internal Audit.
  • Quality Connection This subscription assists with your existing quality system, an FDA inspection/response if needed, or other quality issue. Includes consulting when needed, FDA assistance, online educational training courses, and quality news pertinent to your business.
  • Quality Consulting Already have a quality system in place or considering implementing one and have some specific questions about your business? Contact us for quality guidance or assistance with an FDA inspection/response. Hourly consulting available.
  • FDA Registration Businesses that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. SafeLink can help you determine if your business is required to register and guide you through the process.
  • 510(k) Submission Guidance Dental laboratories may need to submit to FDA a Premarket Notification, more commonly referred to as a 510(k), for products that are required to show safety and efficacy prior to placing them on the market. This can include intraoral sleep appliances, sequential aligners, TMJ and Bruxism splints, and customized in-house milled implant abutments. SafeLink Consulting can assist you in determining if your business model meets this requirement and provide guidance.
We appreciate the assistance we’ve received from SafeLink Consulting in helping us to understand the complexities of our regulatory systems. Beyond the effort of creating a comprehensive quality management system is the opportunity to work on overall efficiency within the organization, and the peace of mind that comes with it.

Scott, Udell Dental Laboratory

DAMAS Certification or Recertification

Is your business ready to become DAMAS certified, or seeking DAMAS renewal of certification / DAMAS recertification? SafeLink provides DAMAS consulting services to help you structure your quality system to comply with DAMAS specifications. SafeLink is an approved DAMAS Certification Auditor. DAMAS provides a system that assists labs operate in compliance with product safety. It provides quality guidelines to help labs improve documentation from dental prescriptions to material traceability.  Learn more about DAMAS Certification. Contact us to learn more about compliance solutions.

I have worked with the SafeLink team throughout my tenure as the OSHA coordinator within my family’s dental laboratory. I am grateful for their help ensuring that we meet all safety requirements to keep both our laboratory family and the dentists we work with safe. From Mary and Gary’s knowledge, to Sandy’s uncanny ability to coordinate laboratory visits (even during COVID), the entire team is amazing! I have had the pleasure of attending courses presented by Gary at LMT’s Lab Day, worked one-on-one with Mary on standards and protocols within the lab, and have had the pleasure of having Gary on-site to comb through every corner of our physical facility to guarantee that we are OSHA compliant. The SafeLink team takes a strict industry and infuses their knowledge, friendly personalities, and most important, their humor to make the process enjoyable. I appreciate the knowledge that comes from every interaction with their team and rely on them when I need guidance.

Scott U.
Dental Laboratory Owner

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