FDA Recognizes Orthodontic Coil Spring Standard in Dental Standards Update

Edited by Orthotown staff

ISO 17254, which covers coiled springs used in orthodontics, is now among the consensus standards the Food and Drug Administration recognizes for medical device premarket reviews. The recognition came in a notice published Aug. 24 in the Federal Register.

The standard entered the list as recognition No. 4-392, citing the first edition dated July 2016 together with Amendment 1 from 2020. It is one of 31 dental standards the agency added in the same notice.

Recognition List No. 066 modifies the standards the FDA recognizes for use in premarket submissions. A manufacturer that elects to declare conformity with a recognized standard may use that declaration to meet certain requirements for a device. The modifications became applicable Aug. 24.

Two other additions touch digital fabrication and record-keeping. ISO 23298 sets 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 remaining dental entries, numbered 4-369 through 4-399, run across clinical instruments and laboratory materials. Seven cover periodontal curettes, scalers, and probes. Three parts of ISO 9173 address extraction forceps. Three parts of ISO 13078 set test methods for dental furnaces, covering temperature measurement, firing glaze evaluation, and high-temperature sintering.

Others cover casting investments and refractory die materials, duplicating materials, denture adhesives, magnetic attachments, reprocessable cartridge syringes for intraligamentary injections, stainless steel for dental instruments, and the bonding test between polymer teeth and denture base materials.

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 ISO 4823 on elastomeric impression and bite registration materials was withdrawn and replaced by a newer sixth edition dated June 2025.

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

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