510(k) K153645
K153645 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH Co. for the device "VITA ENAMIC Implant Solutions (IS)". The FDA issued a decision of Substantially Equivalent on Jun 30, 2016. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Vita Zahnfabrik H.Rauter GmbH Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2016
- Date Received
- Dec 21, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abutment, Implant, Dental, Endosseous
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
- 510(k)
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.