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

Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer

21 CFR 872.3450 / Dental
FDA source (opens on fda.gov)

KXX is the FDA product code for Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer, a class I device type, regulated under 21 CFR 872.3450. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KXX
Device name
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Regulation
21 CFR 872.3450
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 KXX

By decision year
1 clearance under product code KXX with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KXX by decision year
YearClearances
19861

Applicants with the most clearances

Product code KXX
Applicants holding the most 510(k) clearances under product code KXX
ApplicantClearances
Combe, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code