# K251294: Bonafix Implant Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Zentek Medical, LLC
- Decided: Oct 15, 2025 after 173 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: 21 generations back to K960026 (1996). 324 ancestors in all.
No later device cites it as a predicate yet.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221673: Bonafix TiBase, Zentek Medical, LLC (2023) Summary page 6.

## Indications for use
Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. Compatible Implant Systems Dental implant System Implant Body Diameter (mm) Platform Diameter Neodent GM 3.5, 3.75, 4.0, 4.3, 5.0 Single Platform Nobel Replace 3.5 NP 4.3 RP 5.0 WP Biomed 3I Certain 3.4 3.4 4.1 4.1 5.0 5.0 Straumann Tissue Level 4.1, 4.8 RN 4.8 WN Astratech 3.5, 4.0 Small 4.5, 5.0 Large Straumann BLX 3.5, 3.75, 4.0, 4.5 RB Megagen AnyRidge 4.0, 4.4 Regular 4.9, 5.4, 5.9 Wide Megagen AnyOne 3.9 3.5 4.3, 4.8, 5.3, 6.3 3.9 All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.

Source page: https://510kreport.com/device/K251294
Methodology: https://510kreport.com/methodology