Cleared Traditional

K942667 - DENT-O-CRYL ORTHODONTIC ACRYLIC

K942667 is an FDA 510(k) clearance for DENT-O-CRYL ORTHODONTIC ACRYLIC, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code KMY cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K942667 · Dentauraum, Inc. · Dental device
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Feb 1995
Decision
252d
Days
Class 1
Risk

K942667 is an FDA 510(k) clearance for the DENT-O-CRYL ORTHODONTIC ACRYLIC. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 252 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K942667

510(k) Number K942667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date February 13, 1995
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

KMY Device Classification - Class 1, General Controls

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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.