SIMPLANT Guide
FDA 510(k) clearance K170849 · decided 2017-06-15
Clearance details
- K-number
- K170849
- Device name
- SIMPLANT Guide
- Applicant
- Dentsply Sirona
- Decision
- Substantially Equivalent
- Date received
- 2017-03-22
- Decision date
- 2017-06-15
- Days to decision
- 85 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
+ Add to Predicate Builder ◉ Watch Dentsply Sirona
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Simplant Digital Guide (K193405) | Dentsply Sirona | 2020-09-02 |
| CEREC Guides (K190059) | Dentsply Sirona | 2019-09-27 |
| SPI VECTODRILL CERAMIC DRILLS (K070290) | Thommen Medical AG | 2007-04-17 |
Recalls involving this device
No recalls on record reference this clearance.