Alpha-Lock or Pro-Lock Fluoride Releasing Glass Ionomer Band Cement
510(k) K942596
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942596 | Date16 Jun 1994 | 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- Withdrawn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
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a glass ionomer cement used in dental applications to bond orthodontic bands to teeth. Glass ionomer cements are self-curing materials composed of a powdered glass and a liquid polyalkenoic acid, which harden to form a durable, adhesive bond. The fluoride-releasing formulation provides additional remineralisation benefits to tooth enamel, helping to prevent decay. It is classified under product code EMA (Dental Cements) and falls under FDA Class II regulatory controls.
The Alpha-Lock or Pro-Lock Fluoride-Releasing Glass Ionomer Band Cement is supplied as a two-part system for in-office use by dental professionals. It is intended for single-use applications and requires proper mixing before application to secure orthodontic bands. The device is regulated under FDA 510(k) clearance (K942596) and adheres to the special controls outlined in regulation 872.3275. No specific sterility or MRI safety information is provided in the available data.