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

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

21 CFR 872.3540 / Dental
FDA source (opens on fda.gov)

NKJ is the FDA product code for Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter, a class I device type, regulated under 21 CFR 872.3540. FDA's definition for this code reads: "OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NKJ
Device name
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
FDA definition
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
Regulation
21 CFR 872.3540
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
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order