510(k) K180184
K180184 is an FDA 510(k) premarket notification submitted by Dentalpoint AG for the device "Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System". The FDA issued a decision of Substantially Equivalent on Nov 16, 2018. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Dentalpoint AG has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2018
- Date Received
- Jan 23, 2018
- Clearance Type
- Traditional
- 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.