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
ELKClass I

Teeth, Artificial, Backing And Facing

21 CFR 872.3910 / Dental
FDA source (opens on fda.gov)

ELK is the FDA product code for Teeth, Artificial, Backing And Facing, a class I device type, regulated under 21 CFR 872.3910. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELK
Device name
Teeth, Artificial, Backing And Facing
Regulation
21 CFR 872.3910
Device class
Class I
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
2
Ingested recalls
0

Clearances, product code ELK

By decision year
2 clearances under product code ELK with a decision year between 1976 and 1981, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELK by decision year
YearClearances
19761
19811

Applicants with the most clearances

Product code ELK
Applicants holding the most 510(k) clearances under product code ELK
ApplicantClearances
J. Aderer, Inc.1
Plastics/Packaging1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order