Cleared Traditional

K880849 - EXAMIX DISPENSER

K880849 is an FDA 510(k) clearance for EXAMIX DISPENSER, manufactured by G-C Intl. Corp.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K880849 · G-C Intl. Corp. · Dental device
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May 1988
Decision
71d
Days
Class 1
Risk

K880849 is an FDA 510(k) clearance for the EXAMIX DISPENSER. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 71 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

FDA 510(k) Submission Details - K880849

510(k) Number K880849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 11, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
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.

Regulatory Peers - EKJ Burnisher, Operative

All 18
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K880849.
BENDA BRUSH
K885162 · Centrix, Inc. · Jan 1989
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
CENTRIX NEEDLETUBE
K882651 · Centrix, Inc. · Aug 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988
BEACH AMALGAM CARRIER, GUN TYPE
K821779 · Pacific Dental Corp. · Jul 1982