Provecta 3D Prime and Provecta 3D Prime Ceph— 510(k) K232487
Substantially EquivalentDurr Dental SE
FDA 510(k) clearance K232487 for Provecta 3D Prime and Provecta 3D Prime Ceph, Substantially Equivalent on 2023-09-14. Applicant: Durr Dental SE. Device class: 2.
Clearance details
- Applicant
- Durr Dental SE
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bietigheim-Bissingen, DE
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