← FDA Medical Device Classifications
External Cleaning Solution
PME · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3260
Classification
- FDA Product Code
PME- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 872.3260
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 14
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown