# K222984: BioClean Implant Restorative System

- Pathway: 510(k) (Traditional)
- Applicant: Bioclean Dental, LLC
- Decided: Dec 29, 2022 after 92 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191123: Multi-unit Abutments, Medentika GmbH (2020) Summary page 4.

## Indications for use
The BioClean Implant Restorative System is designed to support fixed/detachable partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed/detachable restorations that can be attached with a friction-based engagement system. All digitally designed copings for use with the BioClean Implant Restorative System are to be sent to BioClean Dental or a validated milling center for manufacture. The BioClean Implant Restorative System is compatible with the following: BioClean Implant Restorative System Compatibility Implant Components Configurations Bone Level Straumann Multi-Unit Abutments NC/RC 4.6mm Platform Diameter, All Gingival Heights Straumann Multi-Unit Abutment Occlusal Screw

Source page: https://510kreport.com/device/K222984
Methodology: https://510kreport.com/methodology