EFT · Cleanser, Denture, Over The Counter
Dental · 21 CFR 872.3520 · Class 1
Overview
| Product Code | EFT |
|---|---|
| Device Name | Cleanser, Denture, Over The Counter |
| Regulation | 21 CFR 872.3520 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080631 | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | Oral Health Technologies, LLC | May 23, 2008 | SESE |
| K051342 | MEDICAL INTERPOROUS | Bonyf AG | Jun 2, 2006 | SESE |
| K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl. | Jun 16, 2000 | SESE |
| K942203 | OTC DENTURE CLEANSER | Combe, Inc. | Aug 10, 1994 | SESE |
| K930337 | PROFAST(R)-DENTURE CLEANSER | Fittydent-Altwirth & Schmitt GmbH | Sep 7, 1993 | SESE |
| K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. | Jan 13, 1993 | SESE |
| K925259 | CFR MONOGRAPH | Combe, Inc. | Jan 11, 1993 | SESE |
| K902838 | DENTURE DYNAMIC'S DENTURE MAGIC | Denture Dynamic'S, Inc. | Sep 6, 1990 | SESE |
| K903686 | ARGILITE 4 GOLD ALLOY FOR PORCELAIN | Argen Precious Metals, Inc. | Aug 29, 1990 | SESE |
| K895345 | ORAD TOOTHBRUSH CLEANER | Orad, Inc. | Mar 7, 1990 | SESE |
| K890043 | DENTCLEAN CONCENTRATED DENTURE CLEANSER | K-P Co. | Jun 7, 1989 | SESE |
| K890668 | CLEAN DENT | Lincoln Park Dental Laboratory | Apr 17, 1989 | SESE |
| K880068 | EFFERVESCENT DENTURE CLEANSER | Perrigo Co. | Mar 7, 1988 | SESE |
| K874805 | TATUNG'S DENTURE CLEANING SOLUTION | Tatung Company of America, Inc. | Feb 16, 1988 | SESE |
| K871785 | DENTURE CLEANSING TABLET | Pennex Products Co., Inc. | Sep 11, 1987 | SESE |
| K854995 | DENCLENZ | Creighton Products Corp. | May 12, 1986 | SESE |
| K860118 | SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 | Northern Electric Co. Div. of Sunbeam Corp. | Apr 17, 1986 | SESE |
| K860737 | TEEN CLEAN, RETAINER CLEANER | Teen Care, Inc. | Mar 26, 1986 | SESE |
| K851183 | PEPSODENT DENTURE CLEANSER PDP FORMULA | Lever Brothers Company, Inc. | Apr 29, 1985 | SESE |
| K851182 | PEPSODENT DENTURE CLEANSER-WESTONE FORMULA | Lever Brothers Company, Inc. | Apr 29, 1985 | SESE |
Top Applicants
- Lever Brothers Company, Inc. — 2 clearances
- Combe, Inc. — 2 clearances
- Teen Care, Inc. — 1 clearance
- Tatung Company of America, Inc. — 1 clearance
- Richardson-Vicks, Inc. — 1 clearance
