Cleared Traditional

ADA SHANK EXTENSION (K914724) - FDA 510(k) Clearance

Class I Dental device.

K914724 · Implant Corp. of America · Dental device
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Jul 1993
Decision
648d
Days
Class 1
Risk

K914724 is an FDA 510(k) clearance for the ADA SHANK EXTENSION. Classified as Drill, Dental, Intraoral (product code DZA), Class I - General Controls.

Submitted by Implant Corp. of America (St. Petersburg, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 648 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4130 - 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 Implant Corp. of America devices

Submission Details

510(k) Number K914724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date July 27, 1993
Days to Decision 648 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
521d slower than avg
Panel avg: 127d · This submission: 648d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZA Drill, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4130
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.