510(k) clearance
Hygienic Protective Bite Cover (2207-010-50)
- 510(k) number
- K262073
- Applicant
- Dürr Dental SE
- Decision date
- Sep 17, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PEM
- Device type
- Dental Barriers And Sleeves
- Device class
- Class II
- Regulation
- 21 CFR 878.4370
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Bietigheim-Bissingen, DE