CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
FDA 510(k) clearance K080240 · decided 2008-02-07
Clearance details
- K-number
- K080240
- Device name
- CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
- Applicant
- Promident, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-01-31
- Decision date
- 2008-02-07
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New City, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.