Cleared Traditional

K964179 - SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS

K964179 is an FDA 510(k) clearance for SUPER-DENT ETCHING GEL, manufactured by S.S. White Mfg., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K964179 · S.S. White Mfg., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
83d
Days
Class 2
Risk

K964179 is an FDA 510(k) clearance for the SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL .... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by S.S. White Mfg., Ltd. (Gloucester, GB). The FDA issued a Cleared decision on January 9, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 S.S. White Mfg., Ltd. devices

FDA 510(k) Submission Details - K964179

510(k) Number K964179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date January 09, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 724
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K964179.
WHITE CORE
K964931 · Bisco, Inc. · Feb 1997
ULTRA-ETCH STAT
K965060 · Ultradent Products, Inc. · Jan 1997
TETRIC CERAM
K964285 · Ivoclar North America, Inc. · Jan 1997
FIBREKOR
K964578 · Jeneric/Pentron, Inc. · Dec 1996
COJET SYSTEM
K963735 · Espe GmbH & Co. Kg. · Nov 1996
PRODIGY AC
K963805 · Sybron Dental Specialties, Inc. · Nov 1996