# K221673: Bonafix TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Zentek Medical, LLC
- Decided: Jul 14, 2023 after 400 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: 20 generations back to K960026 (1996). 323 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212108: Dynamic TiBase, Talladium España, SL (2021) Summary page 4.

## Most influential descendants
- K251294: Bonafix Implant Abutments (2025), 0 descendants of its own

## Indications for use
Bonafix TiBase 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 System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) HIOSSEN ET III | 3.5 Mini | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular Nobel Active |3.5 NP | 4.3, 5.0 |RP Straumann Bone Level |3.3 NC | 4.1, 4.8 |RC Zimmer Screw-Vent/ |3.3, 3.7, 4.1 13.5 Tapered Screw Vent |4.7 |4.5 | 6.0 15.7 Bonafix 2 Plus Implants | 3.5, 3.75, 4.20, 5.0, 6.0 |3.5 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/K221673
Methodology: https://510kreport.com/methodology