Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
The OTC Wax-Impregnated Cotton Denture Cushion or Pad is a dental accessory device applied by the patient to the base or inner surface of a denture before insertion to improve fit and comfort, intended to be discarded after one day's use. It is classified as FDA Class 1 (General Controls), under product code NKJ and regulation 21 CFR 872.3540 in the Dental specialty. The device is not GMP exempt, not an implant, and not life-sustaining.
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Basic Information
- Product Code
- NKJ
- Device Class
- FDA class 1
- Regulation Number
- 872.3540
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.