FDA Compliance for Dental Impression Materials & Digital Scanners

Dental impression materials & digital scanners are widely used in restorative & orthodontic treatments, ensuring precision in dental prosthetics & aligners. Because these devices play a crucial role in patient outcomes, the FDA enforces strict regulatory controls to ensure safety & accuracy. Manufacturers marketing impression materials or intraoral scanners in the US must comply with medical device regulations, classification requirements & labeling standards. Non-compliance can lead to Import Alerts, detentions & enforcement actions.

How the FDA Classifies Dental Impression Products

FDA classification is based on risk level & device functionality:

Class I (Low Risk): Basic impression trays & mixing spatulas. Typically exempt from 510(k) but require Establishment Registration & Medical Device Listing.
Class II (Moderate Risk): Alginate, PVS & other elastomeric impression materials. These require 510(k) clearance.
Class II (Moderate Risk): Digital intraoral scanners & CAD/CAM impression systems. Also require 510(k) clearance.

Steps to Enter the US Market

Manufacturers must complete several regulatory steps before distributing impression materials or scanners:

Establishment Registration: Required annually for all manufacturers & importers.
Medical Device Listing: Each product must be listed under the registered establishment.
UDI Compliance: Most digital scanners require a Unique Device Identifier for traceability.
Labeling & Advertising Compliance: Packaging & claims must meet FDA regulations.

Common Compliance Challenges & Solutions

Even experienced manufacturers can face unexpected regulatory hurdles. The following examples highlight the importance of preparation:

Case Study: Digital Impression Scanner Detained Due to UDI Non-Compliance

A manufacturer attempted to launch an intraoral scanner in the US but was detained due to missing UDI labeling:

Shipments delayed while compliance updates were implemented.
Packaging redesigned & UDI data submitted to GUDID.
Regulatory consultants engaged to prevent future detentions.

Case Study: Incorrect Classification of a New Impression Material

A company misclassified a self-curing impression material as Class I. The FDA reclassified it as Class II:

Product launch delayed while conducting safety testing.
Additional costs incurred for regulatory submissions.
Filed a 513(g) request to clarify classification before future development.

Regulatory Considerations for Manufacturers

FDA User Fees: Required annually; Small Business Fee Assistance may apply.
Import Alerts: Violations can result in blocked shipments.
Certificate to Foreign Government (CFG): Needed for international exports.
Health Canada Licensing: MDEL required to distribute in Canada.

Maintaining Compliance After Market Entry

Approval is only the beginning. Ongoing responsibilities include:

eMDR Submissions: Report device-related malfunctions or adverse events.
FOIA Requests: Access regulatory data on comparable devices.
Medical Device Master File: Streamlines future approvals.
Ongoing Regulatory Consulting: Ensures alignment with FDA updates.

Setting the Stage for Regulatory Success

Bringing dental impression materials & scanners to the US market requires more than approval—it demands continuous regulatory alignment. Manufacturers that correctly classify devices, follow UDI & labeling rules & engage regulatory support will enter the market with confidence & maintain long-term success.

Marco Theobold

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.