D-23 Denture Adhesive
510(k) K871980
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871980 | Date5 Jun 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6080
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
D-23 Denture Adhesive is a dental device classified under product code KOJ and regulation number 872.6080. It is a denture adhesive intended for use in securing dentures in the oral cavity.
The device was cleared via the FDA 510(k) pathway under submission K871980, with a decision date of June 5, 1987. It is manufactured by Solar Dental Co., Inc. and is intended for prescription or over-the-counter use as indicated by its classification and intended use in dental applications.
Other devices from Solar Dental Co., Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the D-23 Denture Adhesive used for?
The D-23 Denture Adhesive is intended for use in securing dentures in the oral cavity, as stated in its description and intended use for dental applications.
How was the D-23 Denture Adhesive authorized for market?
The device was cleared via the FDA 510(k) pathway under submission K871980, with a decision date of June 5, 1987, indicating it was found substantially equivalent to a legally marketed device.
Who manufactures the D-23 Denture Adhesive and where is it located?
The D-23 Denture Adhesive is manufactured by Solar Dental Co., Inc., located at 111n. Wabash, Chicago, IL 60602, United States, as provided in the device data.