Gk-101E Caries Removal Agent/System
by Indevus Pharmaceuticals, Inc.
PMA P830035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830035 | Date18 Apr 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- SOLUTION, REMOVAL, CARRIES
- PMA Number
- FDA Product Code
- LMW
- Device Class
- Class III
- Advisory Committee
- Dental
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The GK-101E Caries Removal Agent System is a dental solution designed for the removal of caries. This system is classified under the dental advisory committee for clinical applications.
This device is manufactured by Indevus Pharmaceuticals, Inc. and is identified by PMA number P830035. It has received FDA PMA authorization for its intended use in dental procedures.
Questions
AI-generated answers, 18 Sep 2026
What is the GK-101E Caries Removal Agent System used for?
The GK-101E is a dental solution specifically indicated for the removal of caries, assisting dental professionals in the treatment of tooth decay.
Who is the manufacturer of this device?
The GK-101E Caries Removal Agent System is manufactured by Indevus Pharmaceuticals, Inc., located in Cranbury, New Jersey.
Is this device FDA authorized?
Yes, the device has received FDA PMA authorization, as indicated by the PMA number P830035.