← FDA Medical Device Classifications
Dental Barriers And Sleeves
PEM · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4370
Classification
- FDA Product Code
PEM- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4370
- Review panel
- DE
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Market data
- Cleared 510(k) submissions
- 15
- Registered establishments
- 45
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown