VIP- VARIABLE INTENSITY POLYMERIZER
FDA 510(k) clearance K000426 · decided 2000-04-12
Clearance details
- K-number
- K000426
- Device name
- VIP- VARIABLE INTENSITY POLYMERIZER
- Applicant
- Bisco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-09
- Decision date
- 2000-04-12
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- EBZ
- Device class
- 2
- Regulation number
- 872.6070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.