FDA-recognized standard · Dental/ENT
ANSI ADA 41-2020: Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Yes. FDA recognizes ANSI ADA Standard No. 41-2020 as recognition 4-295, entered 2022-12-19.
Recognized editions of ANSI ADA 41-2020
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-295 | ANSI ADA Standard No. 41-2020 | 2022-12-19 | Complete | — |
Regulations
FDA lists these classification regulations against ANSI ADA 41-2020: 21 CFR 872.3060, 21 CFR 872.3070, 21 CFR 872.3275, 21 CFR 872.3300, 21 CFR 872.3310, 21 CFR 872.3330, 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 872.3920, 21 CFR 872.5470, 21 CFR 872.5525, 21 CFR 872.5550, 21 CFR 872.5570, 21 CFR 872.5571, 21 CFR 872.5575, 21 CFR 872.5580, 21 CFR 872.6030, 21 CFR 872.6660.
Product codes that cite ANSI ADA 41-2020
40 FDA product codes cite ANSI ADA 41-2020, including ADA, DYH, DYW, EBC, EBD.
- ADA
- DYH Adhesive, Bracket And Tooth Conditioner, Resin
- DYW
- EBC
- EBD
- EBE
- EBF Material, Tooth Shade, Resin
- EBI Resin, Denture, Relining, Repairing, Rebasing
- EIH Powder, Porcelain
- EJH
- EJJ
- EJR
- EJS
- EJT
- ELL
- ELW Material, Impression
- ELY
- ELZ
- EMA Cement, Dental
- EMB
- KIF Resin, Root Canal Filling
- KKO
- KMY
- KZP
- LQZ
- LRK Device, Anti-Snoring
- MEF
- MYB
- MZW
- NJM Bracket, Ceramic, Orthodontic
- NTO
- NXC Aligner, Sequential
- OHP
- OIV
- ORY
- OZR
- PLC
- POW
- QCJ
- QNO
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.