Cleared Traditional

K945256 - MTC 7707 HIGH SPEED AIR TURBINE

K945256 is an FDA 510(k) clearance for MTC 7707 HIGH SPEED AIR TURBINE, manufactured by Mtc Industries and Research, Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K945256 · Mtc Industries and Research, Ltd. · Dental device
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Jan 1996
Decision
458d
Days
Class 1
Risk

K945256 is an FDA 510(k) clearance for the MTC 7707 HIGH SPEED AIR TURBINE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Mtc Industries and Research, Ltd. (Carmiel, IL). The FDA issued a Cleared decision on January 29, 1996 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Mtc Industries and Research, Ltd. devices

FDA 510(k) Submission Details - K945256

510(k) Number K945256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date January 29, 1996
Days to Decision 458 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
331d slower than avg
Panel avg: 127d · This submission: 458d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 137
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