Cleared Traditional

APPLICATOR, LEE IMPRESSION (K781977) - FDA 510(k) Clearance

Class I Dental device.

K781977 · Lee Pharmaceuticals · Dental device
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Dec 1978
Decision
23d
Days
Class 1
Risk

K781977 is an FDA 510(k) clearance for the APPLICATOR, LEE IMPRESSION. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Lee Pharmaceuticals devices

Submission Details

510(k) Number K781977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date December 20, 1978
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EID Syringe, Restorative And Impression Material
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.