FDA-recognized standard · Dental/ENT
ISO 22052: Dentistry - Compressed air source equipment
Yes. FDA recognizes ISO 22052 First edition 2020-06 as recognition 4-306, in part, entered 2023-05-29.
Recognized editions of ISO 22052
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-306 | ISO 22052 First edition 2020-06 also ANSI ADA Standard No. 94-2021 | 2023-05-29 | Partial | — |
What FDA does not recognize in ISO 22052 First edition 2020-06
Recognition 4-306 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.1 Electrical Safety Clause 5.2 Electromagnetic Compatibility
Regulations
FDA lists these classification regulations against ISO 22052: 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4565, 21 CFR 872.4840, 21 CFR 872.6080, 21 CFR 872.6640.
Product codes that cite ISO 22052
19 FDA product codes cite ISO 22052, 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
- KMW
- KOJ
- NRD
- NYL
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.