Cleared Traditional

K991283 - DYNA TORQ TORQUE WRENCH, TORQUE WRENCH

K991283 is an FDA 510(k) clearance for DYNA TORQ TORQUE WRENCH, manufactured by Micro Motors, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K991283 · Micro Motors, Inc. · Dental device
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Aug 1999
Decision
125d
Days
Class 2
Risk

K991283 is an FDA 510(k) clearance for the DYNA TORQ TORQUE WRENCH, TORQUE WRENCH. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Micro Motors, Inc. (Irvine, US). The FDA issued a Cleared decision on August 18, 1999 after a review of 125 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.

FDA 510(k) Submission Details - K991283

510(k) Number K991283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date August 18, 1999
Days to Decision 125 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
3d faster than avg
Panel avg: 128d · This submission: 125d
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 1477
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K991283.
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA
K992512 · Imcor · Nov 1999
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · Implant Innovations, Inc. · Oct 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999
BICORTICAL SCREW
K983120 · Oraltronics Marketing-Und Vertriebs GmbH · Jul 1999
SYNOCTA PROSTHETICS
K990342 · Straumann USA · Jul 1999
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
K990304 · Astra Tech, Inc. · Jul 1999
K991283 · DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
Download PDF Micro Motors, Inc.