Regulatory Notice
The following information does not constitute legal advice, and you should check with your state or your legal team before implementing anything based on information read on this site. Regulations change, interpretations vary, and your laboratory is responsible for confirming the current requirements that apply to its own work.
Dental laboratories occupy a unique position within the medical device industry.
Unlike manufacturers that produce thousands of identical medical devices, dental laboratories manufacture patient-specific restorations from a licensed dentist's prescription. Every crown, denture, bridge, nightguard, or implant restoration is customized for a single patient.
Because of this, dental laboratories are generally considered medical device customizers, not traditional mass manufacturers.
The distinction is important.
A denture, for example, is a medical device. However, the laboratory is not developing or mass-producing a new denture design. Instead, it is taking FDA-cleared materials, components, and manufacturer-approved manufacturing processes and customizing them for one patient according to a prescription.
In practical terms, a dental laboratory's manufacturing batch is almost always one device for one patient.
This is why the FDA requires dental laboratories to maintain documentation, traceability, and quality controls while recognizing that their manufacturing process differs from companies producing identical devices in large quantities.
Historically, the FDA regulated medical device manufacturers under 21 CFR Part 820, commonly called the Quality System Regulation (QSR).
The purpose of the regulation is straightforward:
Build every medical device using controlled, documented, repeatable processes so the finished product is safe and performs as intended.
For dental laboratories, this means documenting not only how restorations are manufactured, but also proving that each patient-specific restoration was produced according to the prescribed requirements.
A Quality System (QS) is the collection of policies, procedures, records, training, and management practices that allow a laboratory to consistently manufacture safe, effective dental devices.
The FDA defines a Quality System as:
The organizational structure, responsibilities, procedures, processes, and resources used to implement quality management.
A complete Quality System includes:
A Quality System is much larger than Quality Control alone.
These terms are closely related.
GMP refers to manufacturing products using documented, repeatable processes that consistently produce acceptable results.
The FDA uses the term Current Good Manufacturing Practice because manufacturers are expected to follow today's accepted methods--not outdated practices.
The Quality System is the documented framework a laboratory uses to implement Good Manufacturing Practices every day.
Simply put:
GMP is the philosophy.
The Quality System is how you prove you're following it.
Historically, the FDA regulated medical device manufacturers under 21 CFR Part 820, commonly known as the Quality System Regulation (QSR). The concepts of Quality Systems (QS) and Current Good Manufacturing Practices (cGMP/GMP) formed the foundation of FDA quality requirements for decades.
In 2024, the FDA adopted the Quality Management System Regulation (QMSR), which harmonizes FDA quality requirements with the international standard ISO 13485:2016.
This change was not intended to eliminate quality requirements. It was intended to align the United States with the same quality management framework already used throughout much of the world.
Many existing dental laboratory resources, including DAMAS documentation, older quality manuals, and the CDT examination, still teach the older QS/GMP terminology. Students should therefore understand both systems.
The relationship can be understood this way:
The Dental Appliance Manufacturers Audit System (DAMAS) was developed during the era of the FDA Quality System Regulation and is built around traditional QS/GMP principles. Although the FDA has transitioned to the Quality Management System Regulation (QMSR), the fundamental concepts of documentation, traceability, process control, corrective action, training, audits, and continuous improvement remain the same.
Because of this, laboratories using DAMAS already implement many of the same quality management principles found in ISO 13485. The terminology has evolved, but the underlying goal--consistently producing safe, high-quality dental devices through documented and controlled processes--has not.
CDT Exam Note: The NBC CDT examination currently emphasizes the traditional FDA Quality System (QS/GMP) terminology rather than the newer QMSR/ISO 13485 language. Learn the historical terminology for the exam, but understand that the industry is transitioning toward ISO 13485-based quality management.
ISO 13485 is an international quality management standard for medical device manufacturers.
Unlike FDA regulations, ISO 13485 is not a federal law. Instead, it provides an internationally recognized framework for building and maintaining an effective quality management system.
Many of its requirements closely parallel the FDA Quality System Regulation, including:
The FDA has modernized its Quality Management System Regulation (QMSR) to better harmonize with ISO 13485. However, the CDT examination still primarily references the traditional Part 820 terminology.
The Dental Appliance Manufacturers Audit System (DAMAS) applies Quality System principles specifically to dental laboratories.
Rather than replacing FDA requirements, DAMAS provides dental laboratory-specific guidance for implementing them.
Many laboratories pursue DAMAS certification because it demonstrates a mature, documented quality system and aligns closely with FDA expectations.
The following definitions are among the most important FDA terms for the CDT examination. Most originate from 21 CFR §820.3.
Complaint: Any written, verbal, or electronic communication alleging a deficiency in the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it has been delivered.
Component: Any raw material, substance, part, labeling, or assembly intended to become part of the finished device.
Control Number: A unique identifier that allows the manufacturing history of a device to be traced.
Design Input: The requirements used to manufacture the device. For dental laboratories, this is typically the dentist's prescription, work authorization, and documented design preferences.
Design Output: The completed design information that satisfies the design inputs and becomes the basis for manufacturing.
Device Master Record (DMR) / Device History Record (DHR): Many dental technicians were taught that the Device Master Record (DMR) was the complete documentation for an individual patient case. Older dental laboratory quality manuals and CDT study materials frequently use the term this way.
Device Master Record (DMR): The master documentation describing how a category of devices is manufactured, including manufacturing procedures, specifications, materials, quality procedures, packaging, and labeling.
Device History Record (DHR): The documentation created for one specific device manufactured for one specific patient. In a dental laboratory, this is effectively the complete case file and may include the prescription or work authorization, digital scans or impressions, photographs, shade information, communications with the dental office, prescription changes, material lot numbers, outsourcing records, Quality Control documentation, and shipping documentation.
CDT Exam Tip: Older dental laboratory literature and many CDT study resources still refer to the patient case documentation as the Device Master Record (DMR/MDR). Modern FDA terminology calls this the Device History Record (DHR). For examination purposes, recognize both terms.
Nonconformity: Failure to meet a specified requirement.
Quality: The total characteristics of a device that determine whether it is fit for its intended purpose.
Quality Audit: An independent review performed to verify that the Quality System is functioning as intended.
Quality Policy: Management's overall commitment and direction regarding quality.
Quality System: The complete organizational framework used to consistently manufacture quality devices.
Rework: Correcting a nonconforming product before it is released.
Validation: Objective evidence demonstrating that a process consistently produces acceptable results. Example: validating that a curing process consistently produces properly polymerized acrylic.
Verification: Confirming that specified requirements have been met. Example: verifying that the completed restoration matches the prescription.
Corrective and Preventive Action (CAPA) is the formal process used to investigate quality problems and prevent them from occurring again.
CAPA begins with identifying a problem, determining its root cause, implementing corrective action, and verifying that the solution was effective. It is one of the central concepts in every Quality System.
DentalTechnology.org is dedicated to preserving, teaching, and advancing the craft of dental technology.
This resource is made possible by Russellville Dental Lab, a full-service dental laboratory in Russellville, Kentucky, serving clinicians across the USA for more than 70 years.