Simplant Digital Guide
FDA 510(k) clearance K193405 · decided 2020-09-02
Clearance details
- K-number
- K193405
- Device name
- Simplant Digital Guide
- Applicant
- Dentsply Sirona
- Decision
- Substantially Equivalent
- Date received
- 2019-12-09
- Decision date
- 2020-09-02
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NDP
- Device class
- 1
- Regulation number
- 872.3980
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CEREC Guides (K190059) | Dentsply Sirona | 2019-09-27 |
| SIMPLANT Guide (K170849) | Dentsply Sirona | 2017-06-15 |
| SPI VECTODRILL CERAMIC DRILLS (K070290) | Thommen Medical AG | 2007-04-17 |
Recalls involving this device
No recalls on record reference this clearance.