DENTSPLY PRECISION TORQUE SYSTEM— 510(k) K964046

Name: FDA 510(k) clearance K964046
Creator: U.S. Food and Drug Administration
Published: 1997-03-04

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K964046 for DENTSPLY PRECISION TORQUE SYSTEM, Substantially Equivalent on 1997-03-04. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1996-10-09
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Dentsply Intl.

view all

K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC2013-02-22
K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2008-03-27
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2007-03-14
K070019 — CARRARA VOLUMIA2007-01-26
K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.