Cleared Traditional

K910090 - DIMAC WIRES

K910090 is an FDA 510(k) clearance for DIMAC WIRES, manufactured by Instrumentations Unltd.. The device is a Class 2 Dental device with product code DYX cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K910090 · Instrumentations Unltd. · Dental device
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Jul 1991
Decision
197d
Days
Class 2
Risk

K910090 is an FDA 510(k) clearance for the DIMAC WIRES. Classified as Lock, Wire, And Ligature, Intraoral (product code DYX), Class II - Special Controls.

Submitted by Instrumentations Unltd. (Quakertown, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 197 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4600 - 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 Instrumentations Unltd. devices

FDA 510(k) Submission Details - K910090

510(k) Number K910090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date July 25, 1991
Days to Decision 197 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYX Device Classification - Class 2, Special Controls

Product Code DYX Lock, Wire, And Ligature, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4600
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.