Cleared Traditional

K940998 - IMPAC TORQUE WRENCH

K940998 is an FDA 510(k) clearance for IMPAC TORQUE WRENCH, manufactured by Vident. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K940998 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
262d
Days
Class 2
Risk

K940998 is an FDA 510(k) clearance for the IMPAC TORQUE WRENCH. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 262 days - an extended review cycle.

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 Vident devices

FDA 510(k) Submission Details - K940998

510(k) Number K940998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1994
Decision Date November 21, 1994
Days to Decision 262 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 127d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1269
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K940998.
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
K944068 · Lifecore Biomedical, Inc. · Feb 1995
KIS-II IMPLANT SYSTEM/DRILLS
K944356 · Implant Center of the Palm Beaches · Dec 1994
VIDENT IMPAC IMPLANT ACCESSORIES
K923395 · Vident · Nov 1994
VIDENT IMPAC INFINITE POSITION ABUTMENT
K941247 · Vident · Nov 1994
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
K941620 · Biomet, Inc. · Sep 1994