# K092403: TI Prepable Abutment, Model 1618, 1619, 1620

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Oct 30, 2009 after 85 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
No predicates in its family tree.
76 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Integral VII 3.25mm Biointegrated Dental Implant System (Fixed Abutment): named in the summary without a submission number

## Most influential descendants
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants of its own

## Indications for use
The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

Source page: https://510kreport.com/device/K092403
Methodology: https://510kreport.com/methodology