Cleared Traditional

REMOLDABLE CRANIOMANDIBULAR APPLIANCE (K833455) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.