ASTRALIS 10, MODELS # 559588, 561859— 510(k) K013275
Substantially EquivalentIvoclar Vivadent, Inc.
FDA 510(k) clearance K013275 for ASTRALIS 10, MODELS # 559588, 561859, Substantially Equivalent on 2001-10-19. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivoclar Vivadent, Inc.
- Product code
- Code EBZ
- Device class
- Class 2
- Regulation
- 21 CFR 872.6070
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amherst, NY, US
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