Cleared Traditional

HYGIENIC RUBBER DAM FRAME (K780746) - FDA 510(k) Clearance

Class I Dental device.

K780746 · Hygienic Dental Mfg., Co., The · Dental device
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May 1978
Decision
29d
Days
Class 1
Risk

K780746 is an FDA 510(k) clearance for the HYGIENIC RUBBER DAM FRAME. Classified as Frame, Rubber Dam (product code EJE), Class I - General Controls.

Submitted by Hygienic Dental Mfg., Co., The (Mchenry, US). The FDA issued a Cleared decision on May 12, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Hygienic Dental Mfg., Co., The devices

Submission Details

510(k) Number K780746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1978
Decision Date May 12, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJE Frame, Rubber Dam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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.