FDA Adds Seven Periodontal Instrument Standards to Recognized Consensus List

Edited by Hygienetown staff

Seven standards governing periodontal curettes, scalers, and probes are now recognized by the Food and Drug Administration for use in medical device premarket reviews, part of a set of 31 dental standards added in a notice published Aug. 24 in the Federal Register.

The periodontal entries include ANSI/ADA Standard No. 113 on periodontal curettes, dental scalers, and excavators, and ANSI/ADA Standard No. 170 covering periodontal probes and discoid-type dental excavators.

Four parts of ISO 13397 also joined the list, addressing general requirements for curettes, scalers, and excavators, Gr-type periodontal curettes, H-type dental scalers, and Jacquette scalers. ISO 21672-1 sets general requirements for periodontal probes.

Recognition List No. 066 modifies the standards the FDA recognizes for premarket submissions. Manufacturers who elect to declare conformity with a recognized standard may use that declaration to satisfy certain requirements for their devices. The modifications became applicable Aug. 24.

The broader dental block, numbered 4-369 through 4-399, extends well past hand instruments. Three parts of ISO 9173 cover extraction forceps. Three parts of ISO 13078 set test methods for dental furnaces. ISO 21850-1 addresses stainless steel used in dental instruments, and ISO 23940 covers excavators.

Other additions reach materials and digital manufacturing, including casting investments and refractory die materials, denture adhesives, duplicating materials, magnetic attachments, a minimal dental implant data set, and test methods for the machining accuracy of computer-aided milling machines.

One existing dental recognition was replaced in a separate table. ISO 4823 on elastomeric impression and bite registration materials was withdrawn in favor of a newer sixth edition dated June 2025.

The FDA issued the notice under the Food and Drug Administration Modernization Act of 1997, filed to docket FDA-2004-N-0451. Comments on the current list of recognized standards may be submitted at any time, and the agency will weigh 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