# K964046: Dentsply Precision Torque System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 4, 1997 after 146 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931440 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931440: Calcitek Torque Wrench System, Calcitek, Inc. (1994) Summary page 1.

## Indications for use
The DENTSPLY® PRECISION TORQUE SYSTEM is used for tightening of prosthetic implant components to their recommended torque levels to deliver an accurate torque application. The SYSTEM can also be used to unthread prosthetic sSCrews.

Source page: https://510kreport.com/device/K964046
Methodology: https://510kreport.com/methodology