Cleared Traditional

K964046 - DENTSPLY PRECISION TORQUE SYSTEM

K964046 is the FDA 510(k) clearance for DENTSPLY PRECISION TORQUE SYSTEM by Dentsply Intl.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K964046 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
146d
Days
Class 2
Risk

K964046 is an FDA 510(k) clearance for the DENTSPLY PRECISION TORQUE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Intl. devices

Submission Details

510(k) Number K964046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1996
Decision Date March 04, 1997
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 127d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K964046.
STERI-OSS TIODIZED SCREW
K964739 · Steri-Oss, Inc. · Mar 1997
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS
K965077 · Implant Innovations, Inc. · Mar 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · Steri-Oss, Inc. · Mar 1997
LIFECORE CONICAL ABUTMENT
K965135 · Lifecore Biomedical, Inc. · Feb 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · Steri-Oss, Inc. · Feb 1997
ROUND DENTAL BUR
K964944 · Steri-Oss, Inc. · Feb 1997