SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
FDA 510(k) clearance K192412 · decided 2020-01-06
Clearance details
- K-number
- K192412
- Device name
- SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
- Applicant
- Dentalez, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-04
- Decision date
- 2020-01-06
- Days to decision
- 124 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.