510(k) K162853
K162853 is an FDA 510(k) premarket notification submitted by Bonafix Surgical And Dental Implants for the device "Bonafix TWO - Dental Implant System". The FDA issued a decision of Substantially Equivalent on Jul 14, 2017. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Bonafix Surgical And Dental Implants has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 2017
- Date Received
- Oct 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)