510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EHRClass II

Pad, Denture, Over The Counter

21 CFR 872.3540 / Dental
FDA source (opens on fda.gov)

EHR is the FDA product code for Pad, Denture, Over The Counter, a class II device type, regulated under 21 CFR 872.3540. As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
EHR
Device name
Pad, Denture, Over The Counter
Regulation
21 CFR 872.3540
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code