FDA Recognizes 31 New Dental Standards in Latest Consensus Standards Update

Edited by Dentaltown staff

The Food and Drug Administration added 31 dental standards to its list of recognized consensus standards in a notice published Aug. 24 in the Federal Register, the largest block in the agency’s latest update.

Recognition List No. 066 modifies the standards the FDA recognizes for use in premarket reviews. Manufacturers who choose to declare conformity with a recognized standard can use that declaration to meet certain requirements for medical devices. The modifications became applicable Aug. 24.

The new dental entries, numbered 4-369 through 4-399, reach across clinical instruments, laboratory materials, and digital manufacturing. Seven cover periodontal curettes, scalers, and probes, including ANSI/ADA Standard No. 113 and four parts of ISO 13397. Three cover extraction forceps under ISO 9173, addressing general requirements, designation, and design.

Laboratory and materials standards make up much of the remainder. Three parts of ISO 13078 set test methods for dental furnaces, covering temperature measurement, firing glaze evaluation, and high-temperature sintering. Others address casting investments and refractory die materials, duplicating materials, denture adhesives, magnetic attachments, and the bonding test between polymer teeth and denture base materials.

Two entries speak to digital workflows. ISO 23298 establishes test methods for the machining accuracy of computer-aided milling machines, and ISO 16498 defines a minimal dental implant data set for clinical use.

The list also picks up ISO 17254 for coiled springs used in orthodontics, ISO 21533 for reprocessable cartridge syringes for intraligamentary injections, ISO 21850-1 on stainless steel for dental instruments, and standards for dental explorers, tweezers, excavators, spoons, and bone curettes.

A separate table replaced one existing dental recognition. ISO 4823 on elastomeric impression and bite registration materials was withdrawn and replaced with a newer sixth edition dated June 2025.

The notice was issued under the Food and Drug Administration Modernization Act of 1997 and filed to docket FDA-2004-N-0451. The FDA accepts comments on the current list of recognized standards at any time and will consider them in deciding whether to amend the list.

Sources:
Federal Register, “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066,” published Aug. 24, 2026: federalregister.gov/documents/2026/08/24/2026-17229