MMU · Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
Dental · 21 CFR 872.3400 · Class 3
Overview
| Product Code | MMU |
|---|---|
| Device Name | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight |
| Regulation | 21 CFR 872.3400 |
| Device Class | Class 3 |
| 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.
Cleared Devices (0)
No cleared devices on record.
