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

Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

21 CFR 872.3410 / Dental
FDA source (opens on fda.gov)

KOL is the FDA product code for Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer, a class I device type, regulated under 21 CFR 872.3410. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KOL
Device name
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
Regulation
21 CFR 872.3410
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 KOL

By decision year
2 clearances under product code KOL with a decision year between 1979 and 1989, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KOL by decision year
YearClearances
19791
19891

Applicants with the most clearances

Product code KOL
Applicants holding the most 510(k) clearances under product code KOL
ApplicantClearances
Iodent, Co.1
Norcliff Thayer, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code