10xAnd
Scoping review

FDA-recognized standard · Dental/ENT

ISO 7405: Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Yes. FDA recognizes ISO 7405 Third edition 2018-10 Corrected version 2018-12 as recognition 4-261, entered 2019-12-23.

Recognized editions of ISO 7405

FDA recognitions of ISO 7405, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 2019-12-23 Complete —

Regulations

FDA lists these classification regulations against ISO 7405: 21 CFR 872.1720, 21 CFR 872.1740, 21 CFR 872.3060, 21 CFR 872.3070, 21 CFR 872.3150, 21 CFR 872.3200, 21 CFR 872.3250, 21 CFR 872.3260, 21 CFR 872.3275, 21 CFR 872.3300, 21 CFR 872.3310, 21 CFR 872.3400, 21 CFR 872.3420, 21 CFR 872.3480, 21 CFR 872.3500, 21 CFR 872.3540, 21 CFR 872.3560, 21 CFR 872.3570, 21 CFR 872.3590, 21 CFR 872.3600, 21 CFR 872.3640, 21 CFR 872.3645, 21 CFR 872.3660, 21 CFR 872.3690, 21 CFR 872.3710, 21 CFR 872.3750, 21 CFR 872.3760, 21 CFR 872.3765, 21 CFR 872.3770, 21 CFR 872.3820, 21 CFR 872.3890, 21 CFR 872.3920, 21 CFR 872.3930, 21 CFR 872.3940, 21 CFR 872.3950, 21 CFR 872.3960, 21 CFR 872.3970, 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4465, 21 CFR 872.4475, 21 CFR 872.4565, 21 CFR 872.4600, 21 CFR 872.4760, 21 CFR 872.4840, 21 CFR 872.4850, 21 CFR 872.4880, 21 CFR 872.4920, 21 CFR 872.5470, 21 CFR 872.5550, 21 CFR 872.5570, 21 CFR 872.6080, 21 CFR 872.6300, 21 CFR 872.6640, 21 CFR 872.6650, 21 CFR 872.6660, 21 CFR 872.6770, 21 CFR 872.6855, 21 CFR 872.6865, 21 CFR 878.3500, 21 CFR 884.4520, 21 CFR 890.3475.

Product codes that cite ISO 7405

82 FDA product codes cite ISO 7405, including DYH, DYW, DYX, DZE, DZH.

The first 80 of 82 are shown.

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.