FDA-recognized standard · Materials
ASTM F603: Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Yes. FDA recognizes ASTM F603-12 (Reapproved 2020) as recognition 8-226, entered 2017-08-21.
Recognized editions of ASTM F603
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-226 | ASTM F603-12 (Reapproved 2020) | 2017-08-21 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F603: 21 CFR 872.3630, 21 CFR 888.3353, 21 CFR 888.3410.
Product codes that cite ASTM F603
8 FDA product codes cite ASTM F603, including KXB, LPF, LZO, MAY, MRA.
- KXB
- LPF
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MRA
- NHA Abutment, Implant, Dental, Endosseous
- OCG
- OQI
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.