21 CFR 872.3400 — Adhesive, Denture, Acacia And Karaya With Sodium Borate
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3400
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KOM | Adhesive, Denture, Acacia And Karaya With Sodium Borate | 1 | 1 | |
| KOR | Adhesive, Denture, Karaya With Sodium Borate | 3 | 0 | |
| MMU | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight | 3 | 0 |
