EHS · Cushion, Denture, Over The Counter
Dental · 21 CFR 872.3540 · Class 2
Overview
| Product Code | EHS |
|---|---|
| Device Name | Cushion, Denture, Over The Counter |
| Regulation | 21 CFR 872.3540 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.
Classification Rationale
Class I if the device is 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. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. 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.
Special Controls
*Classification.* (1) Class I if the device is 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. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. 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. The special controls for this device are FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical—Devices Part I: Evaluation and Testing,’ ” and (ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971002 | SMILE WITH CONFIDENCE | Lloyd V. Ziemendorf | Jul 15, 1997 | SESE |
| K813190 | SOFT PLATE CUSHION | Leonard Russo Co. | Feb 5, 1982 | SESE |
| K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | Combe, Inc. | Jun 24, 1977 | SESE |
Top Applicants
- Combe, Inc. — 1 clearance
- Leonard Russo Co. — 1 clearance
- Lloyd V. Ziemendorf — 1 clearance
