Cleared Traditional

K043301 - GC TION GINGIVAL PROTECTOR

K043301 is an FDA 510(k) clearance for GC TION GINGIVAL PROTECTOR, manufactured by GC America, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K043301 · GC America, Inc. · Dental device
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Jan 2005
Decision
56d
Days
Class 1
Risk

K043301 is an FDA 510(k) clearance for the GC TION GINGIVAL PROTECTOR. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 25, 2005 after a review of 56 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 GC America, Inc. devices

FDA 510(k) Submission Details - K043301

510(k) Number K043301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2004
Decision Date January 25, 2005
Days to Decision 56 days
Submission Type Traditional
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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
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.

Regulatory Peers - EIE Dam, Rubber

All 13
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K043301.
armor LC
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