510(k) K170849
K170849 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "SIMPLANT Guide". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code NDP (Accessories, Implant, Dental, Endosseous), a Class I device regulated under 21 CFR 872.3980. Dentsply Sirona has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2017
- Date Received
- March 22, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Implant, Dental, Endosseous
- Device Class
- Class I
- Regulation Number
- 872.3980
- Review Panel
- DE
- Submission Type