Cleared Traditional

K032289 - FIT CHECKER II

K032289 is an FDA 510(k) clearance for FIT CHECKER II, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K032289 · GC America, Inc. · Dental device
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Oct 2003
Decision
88d
Days
Class 2
Risk

K032289 is an FDA 510(k) clearance for the FIT CHECKER II. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 20, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K032289

510(k) Number K032289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2003
Decision Date October 20, 2003
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K032289.
GC FUSION
K041398 · GC America, Inc. · Jun 2004
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
K041229 · Cosmedent, Inc. · Jun 2004
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
K041028 · Crown Delta Corp. · May 2004
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · Harry J. Bosworth Co. · Oct 2003
TULIP COLORSWITCH
K032116 · Cavex Holland BV · Sep 2003
POLY Q (GARANT L, PENTA M, PENTA H)
K032001 · 3M Espe AG Dental Products · Aug 2003