Cleared Traditional

K970656 - HYDROFLEX

K970656 is an FDA 510(k) clearance for HYDROFLEX, 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 46-day FDA review.

K970656 · GC America, Inc. · Dental device
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Apr 1997
Decision
46d
Days
Class 2
Risk

K970656 is an FDA 510(k) clearance for the HYDROFLEX. 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 April 8, 1997 after a review of 46 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 - K970656

510(k) Number K970656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date April 08, 1997
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
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 K970656.
ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING
K972239 · Zhermack S.P.A. · Aug 1997
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
K972027 · Zhermack S.P.A. · Jul 1997
MEMOREG
K971155 · Heraeus Kulzer, Inc. · May 1997
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
K965083 · S.S. White Mfg., Ltd. · Apr 1997
KALGINATE IMPRESSION MATERIAL
K970594 · Teledyne Water Pik · Mar 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · Dentsply Intl. · Mar 1997