PEM
15 FDA 510(k) clearances · Product code
130 daysmedian time to decision
203 days90th percentile
15clearances measured
FDA profile
- Official device name
- Dental Barriers And Sleeves
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
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Every clearance here is in the API, with alerts when new ones post.