SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
FDA 510(k) clearance K030133 · decided 2003-04-29
Clearance details
- K-number
- K030133
- Device name
- SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
- Applicant
- Dentalez Group
- Decision
- Substantially Equivalent
- Date received
- 2003-01-14
- Decision date
- 2003-04-29
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- EBF
- Device class
- 2
- Regulation number
- 872.3690
- 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.