Cleared Traditional

K833455 - REMOLDABLE CRANIOMANDIBULAR APPLIANCE

K833455 is an FDA 510(k) clearance for REMOLDABLE CRANIOMANDIBULAR APPLIANCE, manufactured by Jeffrey H. Attlin. The device is a Class 1 Dental device with product code KMY cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K833455 · Jeffrey H. Attlin · Dental device
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Jan 1984
Decision
105d
Days
Class 1
Risk

K833455 is an FDA 510(k) clearance for the REMOLDABLE CRANIOMANDIBULAR APPLIANCE. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Jeffrey H. Attlin (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 105 days - within the typical 510(k) review window.

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 Jeffrey H. Attlin devices

FDA 510(k) Submission Details - K833455

510(k) Number K833455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date January 10, 1984
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 128d · This submission: 105d
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.