STARCARE HANDPIECE MAINTENANCE UNIT
FDA 510(k) clearance K093072 · decided 2009-12-28
Clearance details
- K-number
- K093072
- Device name
- STARCARE HANDPIECE MAINTENANCE UNIT
- Applicant
- Dentalez, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-30
- Decision date
- 2009-12-28
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lancaster, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.