KOM · Adhesive, Denture, Acacia And Karaya With Sodium Borate
Dental · 21 CFR 872.3400 · Class 1
Overview
| Product Code | KOM |
|---|---|
| Device Name | Adhesive, Denture, Acacia And Karaya With Sodium Borate |
| Regulation | 21 CFR 872.3400 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or without acacia intended to be applied to the base of a denture before the denture is inserted into patient's mouth to improve denture retention and comfort.
Classification Rationale
(1) Class I (general controls) if the device contains less than 12 percent by weight of sodium borate. 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 III if the device contains 12 percent or more by weight of sodium borate.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910216 | STEADFAST DENTURE ADHESIVE POWDER | Stiefel Research Institute, Inc. | Mar 29, 1991 | SESE |
Top Applicants
- Stiefel Research Institute, Inc. — 1 clearance
