FDA-recognized standard · Dental/ENT
ISO 10637: Dentistry - Central suction source equipment
Yes. FDA recognizes ISO 10637 Second edition 2018-05 as recognition 4-305, in part, entered 2023-05-29.
Recognized editions of ISO 10637
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-305 | ISO 10637 Second edition 2018-05 also ANSI ADA Standard No. 177-2020 | 2023-05-29 | Partial | — |
What FDA does not recognize in ISO 10637 Second edition 2018-05
Recognition 4-305 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.3 Electrical Safety Clause 5.4 Electromagnetic Compatibility
Regulations
FDA lists these classification regulations against ISO 10637: 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4565, 21 CFR 872.4840, 21 CFR 872.6080, 21 CFR 872.6250, 21 CFR 872.6640.
Product codes that cite ISO 10637
18 FDA product codes cite ISO 10637, including DYN, DZH, DZI, DZJ, EBR.
- DYN
- DZH
- DZI Drill, Bone, Powered
- DZJ Driver, Wire, And Bone Drill, Manual
- EBR
- EBW Controller, Foot, Handpiece And Cord
- ECB
- EFA
- EFB Handpiece, Air-Powered, Dental
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- EHZ
- EIA Unit, Operative Dental
- EKX Handpiece, Direct Drive, Ac-Powered
- EKY
- ELB
- KLC
- KOJ
- NRD
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.