ProVecta 3D Prime Ceph— 510(k) K193139
Substantially EquivalentDurr Dental SE
FDA 510(k) clearance K193139 for ProVecta 3D Prime Ceph, Substantially Equivalent on 2020-03-05. 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
- Traditional
- Location
- Bietigheim-Bissingen, DE
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