Who We Serve: Clinical Area
Dental Devices
Dental manufacturers range from small instrument makers to implant companies to producers of resins and printed appliances. Many sell through dealers and distributors, which puts distance between the firm and the people who see problems first. We help dental device makers close the gaps that distance creates.
Standards and Regulations to Know
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 17665Moist Heat Sterilization
- ISO 15223-1Symbols for Medical Device Labeling
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
Typical Regulatory Exposure
Dental devices span the FDA classes. Many hand instruments and accessories are Class I, while impression materials, many restorative materials and endosseous implants are generally Class II, so one firm may hold exempt and cleared products side by side. Exemption, clearance and the quality system obligations that follow from each need to be understood product by product.
Reusable instruments, handpieces and some implant components are reprocessed in the dental office, where steam sterilization is the norm. The manufacturer's reprocessing instructions have to be validated and realistic for that setting. Patient-contacting materials need biological evaluation under the ISO 10993 series, which for resins and printed devices has to reflect the final processed material, not just the raw ingredient.
Digital dentistry has moved design into software. Intraoral scans, design software, milling and 3D printing mean a patient-specific device can be designed and produced through a workflow built from several vendors' software and equipment. The quality system has to show which parts of that workflow the manufacturer controls and how each one is validated.
Where Audits Find Gaps
- 01
Dealer Complaints That Never Arrive
Complaints reach dealers and distributors, but the distribution agreements do not require them to be forwarded, so the complaint file is thinner than reality.
- 02
Reprocessing Instructions Not Realistic for the Office
Instructions specify cleaning or sterilization steps that were never validated, or that a typical dental office cannot carry out as written.
- 03
Printed Device Biocompatibility Based on Raw Resin
The biological evaluation relies on the resin supplier's data, without showing that the firm's printing and post-curing process produces the same finished material.
- 04
Design and Milling Software Not Validated
Software used to design and produce patient-specific devices is treated as off the shelf, with no documented validation for the firm's intended use.
- 05
Labeling and Symbols Inconsistent
Small-format labels use symbols inconsistently or without the required explanation, and translations for export markets were never reviewed against the current version.
Relevant Standards and Regulations
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 17665Moist Heat Sterilization
- ISO 15223-1Symbols for Medical Device Labeling
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Full Audit Readiness Assessment
Documents, records, evidence and interviews, checked against the specific audit you're facing next.
Software Validation and Device Software (CSV, IEC 62304)
Validate software used in production and the QMS, and build device software on an IEC 62304 lifecycle.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
ISO 13485 Certification Readiness
Prepare your QMS, records and people for a certification body's Stage 1 and Stage 2 audits.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Certification Audit (Stage 1 and Stage 2)
The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification.
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
Questions
We make both exempt and cleared devices. Does that complicate the QMS?
Mainly in change control and design records. Each product needs a clear record of its classification and what that requires, so a change to a shared component is evaluated against the most demanding product it affects.
Do we need to validate the software we use to design custom appliances?
Software used in production or the quality system needs validation for its intended use, scaled to the risk. For patient-specific design and manufacturing software, that usually means documented testing of the functions you rely on, not only the vendor's release notes.
How should dealers handle complaints for us?
Define it in the distribution agreement: what counts as a complaint, when it is forwarded and what information comes with it. Then check that it happens, because an investigator who finds complaints in a dealer's records and not in yours will ask why.
Dental Devices
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
