Cleared Special

K070854 - GC MI PASTE PLUS

K070854 is an FDA 510(k) clearance for GC MI PASTE PLUS, manufactured by GC America, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Special 510(k) pathway after a 15-day FDA review.

K070854 · GC America, Inc. · Dental device
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Apr 2007
Decision
15d
Days
Class 1
Risk

K070854 is an FDA 510(k) clearance for the GC MI PASTE PLUS. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on April 12, 2007 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070854

510(k) Number K070854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date April 12, 2007
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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 - EJR Agent, Polishing, Abrasive, Oral Cavity

All 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K070854.
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K070854 · GC MI PASTE PLUS
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