VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
FDA 510(k) clearance K930835 · decided 1994-07-22
Clearance details
- K-number
- K930835
- Device name
- VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
- Applicant
- Ivoclar North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-17
- Decision date
- 1994-07-22
- Days to decision
- 520 days
- Clearance type
- Traditional
- Product code
- ELL
- Device class
- 2
- Regulation number
- 872.3920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Amherst, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.