510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KOMClass I

Adhesive, Denture, Acacia And Karaya With Sodium Borate

21 CFR 872.3400 / Dental
FDA source (opens on fda.gov)

KOM is the FDA product code for Adhesive, Denture, Acacia And Karaya With Sodium Borate, a class I device type, regulated under 21 CFR 872.3400. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KOM
Device name
Adhesive, Denture, Acacia And Karaya With Sodium Borate
Regulation
21 CFR 872.3400
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
1
Ingested recalls
0

Clearances, product code KOM

By decision year
1 clearance under product code KOM with a decision year between 1991 and 1991, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KOM by decision year
YearClearances
19911

Applicants with the most clearances

Product code KOM
Applicants holding the most 510(k) clearances under product code KOM
ApplicantClearances
Stiefel Research Institute, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code