Cleared Traditional

K812692 - FILES & REAMERS

K812692 is an FDA 510(k) clearance for FILES & REAMERS, manufactured by Miltex Instrument Co.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K812692 · Miltex Instrument Co. · Dental device
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Oct 1981
Decision
31d
Days
Class 1
Risk

K812692 is an FDA 510(k) clearance for the FILES & REAMERS. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Miltex Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 31 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 Miltex Instrument Co. devices

FDA 510(k) Submission Details - K812692

510(k) Number K812692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date October 23, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 128d · This submission: 31d
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.