Cleared Traditional

K813378 - UNI-BITE DENTAL X-RAY FILM HOLDER (FDA 510(k) Clearance)

Class I Dental device.

K813378 · Rinn Corp. · Dental device
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Jan 1982
Decision
59d
Days
Class 1
Risk

K813378 is an FDA 510(k) clearance for the UNI-BITE DENTAL X-RAY FILM HOLDER. Classified as Holder, Film, X-ray (product code EGZ), Class I - General Controls.

Submitted by Rinn Corp. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1982 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1905 - 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 Rinn Corp. devices

Submission Details

510(k) Number K813378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date January 29, 1982
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGZ Holder, Film, X-ray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.1905
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.