FDA-recognized standard · Dental/ENT
ISO 21850-1: Dentistry - Materials for dental instruments - Part 1: Stainless steel
Yes. FDA recognizes ISO 21850-1 First edition 2020-04 as recognition 4-395, entered 2026-05-25.
Recognized editions of ISO 21850-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-395 | ISO 21850-1 First edition 2020-04 also ANSI ADA Standard No. 196-2021 | 2026-05-25 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 21850-1: 21 CFR 872.3240, 21 CFR 872.3670, 21 CFR 872.4200, 21 CFR 872.4565, 21 CFR 872.6300, 21 CFR 872.6880.
Product codes that cite ISO 21850-1
70 FDA product codes cite ISO 21850-1, including DZN, EBH, ECB, ECP, ECR.
- DZN
- EBH
- ECB
- ECP
- ECR
- ECS
- ECT
- EEF
- EFA
- EFB Handpiece, Air-Powered, Dental
- EFK
- EFL
- EGI
- EGN
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- EHY
- EIB
- EID
- EIE
- EIF
- EIG
- EIK
- EIL
- EIR
- EIS
- EIX
- EIY
- EJE
- EJG
- EJL
- EJY
- EKA
- EKB
- EKC
- EKD
- EKE
- EKF
- EKG
- EKH
- EKI
- EKJ
- EKK
- EKP
- EKQ
- EKR
- EKS
- EKT
- EKW
- EKX Handpiece, Direct Drive, Ac-Powered
- ELA
- EMD
- EME
- EMG
- EMH
- EMI
- EMJ
- EMK
- EML
- EMM
- EMN
- EMO
- EMP
- EMQ
- EMR
- EMS
- JEP
- JEX
- NYC
- NYF
- NYG
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.