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

Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

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

KOO is the FDA product code for Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt, a class I device type, regulated under 21 CFR 872.3490. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KOO
Device name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
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
4
Ingested recalls
3

Clearances, product code KOO

By decision year
4 clearances under product code KOO with a decision year between 1986 and 1994, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KOO by decision year
YearClearances
19861
19943

Applicants with the most clearances

Product code KOO
Applicants holding the most 510(k) clearances under product code KOO
ApplicantClearances
Block Drug Company, Inc.1
Fittydent-Altwirth & Schmitt GmbH1
Procter & Gamble Co.1
Smithkline Beecham Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order