Riva Protect
by Southern Dental Industries, Inc.
510(k) K050871
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050871 | Date10 Jun 2005 | 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- Withdrawn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
- EBC
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3765
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Riva Protect is a pit and fissure sealant and conditioner used in dental procedures. It is designed to adhere to natural dentition and release fluoride to assist with demineralization.
This device is supplied in capsules and is subject to FDA 510(k) authorization. It is intended for use by dental professionals in a clinical setting.
Other devices from Southern Dental Industries, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the primary clinical use of Riva Protect?
Riva Protect is a pit and fissure sealant and conditioner intended for use by dental professionals in a clinical setting to assist with demineralization.
How is the Riva Protect sealant supplied and how does it function?
The device is supplied in capsules for professional application. It is designed to adhere to natural dentition and release fluoride to support dental health.
What is the regulatory status of this dental sealant?
Riva Protect is subject to FDA 510(k) authorization, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.