# K963951: AS 123 Prosthetic Instrumentation System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Dec 31, 1996 after 90 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Steri-Oss® “Prosthetic Instrumentation”: named in the summary without a submission number
- (no number) Implant Innovations, Inc. “Drivers and Placement Instruments”: named in the summary without a submission number

## Recalls of this device
- Mar 12, 2007 · Not classified · Z-0692-2007: Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Mar 12, 2007 · Not classified · Z-0694-2007: Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Mar 12, 2007 · Not classified · Z-0693-2007: Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

## Indications for use
The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures.

Source page: https://510kreport.com/device/K963951
Methodology: https://510kreport.com/methodology