510(k) K222984
K222984 is an FDA 510(k) premarket notification submitted by Bioclean Dental, LLC for the device "BioClean Implant Restorative System". The FDA issued a decision of Substantially Equivalent on Dec 29, 2022. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 29, 2022
- Date Received
- Sep 28, 2022
- 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.