510(k) K200191
K200191 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Sirona Dental CAD/CAM System with InLab Software". The FDA issued a decision of Substantially Equivalent on August 19, 2020. The device falls under product code PNP (Dental Abutment Design Software For Dental Laboratory), a Class II device regulated under 21 CFR 872.3630. Dentsply Sirona has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2020
- Date Received
- January 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Abutment Design Software For Dental Laboratory
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.