Cleared Traditional

K812260 - DYNA TRAK ENDODONTIC PREP. INSTRUMENT

K812260 is an FDA 510(k) clearance for DYNA TRAK ENDODONTIC PREP. INSTRUMENT, manufactured by Inventive Technology Int'L., Inc.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812260 · Inventive Technology Int'L., Inc. · Dental device
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Aug 1981
Decision
13d
Days
Class 1
Risk

K812260 is an FDA 510(k) clearance for the DYNA TRAK ENDODONTIC PREP. INSTRUMENT. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Inventive Technology Int'L., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inventive Technology Int'L., Inc. devices

FDA 510(k) Submission Details - K812260

510(k) Number K812260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1981
Decision Date August 25, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.