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

Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

21 CFR 872.3490 / Dental
FDA source (opens on fda.gov)

KOT is the FDA product code for Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium, a class I device type, regulated under 21 CFR 872.3490. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KOT
Device name
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Regulation
21 CFR 872.3490
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
8
Ingested recalls
0

Clearances, product code KOT

By decision year
8 clearances under product code KOT with a decision year between 1983 and 1994, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KOT by decision year
YearClearances
19831
19861
19871
19881
19902
19942

Applicants with the most clearances

Product code KOT
Applicants holding the most 510(k) clearances under product code KOT
ApplicantClearances
Block Drug Company, Inc.2
Armkel, LLC1
Johnson & Johnson Professionals, Inc.1
Medical Polymers, Inc.1
Precision Dynamics Corporation1
Stiefel Research Institute, Inc.1
Teledyne Getz1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order