Product code PEM
- Device name
- Dental Barriers And Sleeves
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4370
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
- Source
- FDA openFDA device classification dataset