Cleared Traditional

K812680 - G-C IMPRESSION SYRINGE (FDA 510(k) Clearance)

Class I Dental device.

K812680 · G-C Intl. Corp. · Dental device
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Oct 1981
Decision
14d
Days
Class 1
Risk

K812680 is an FDA 510(k) clearance for the G-C IMPRESSION SYRINGE. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by G-C Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981 after a review of 14 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 G-C Intl. Corp. devices

Submission Details

510(k) Number K812680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date October 06, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
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.