Cleared Traditional

K961190 - GLY-ETCH

K961190 is an FDA 510(k) clearance for GLY-ETCH, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K961190 · Centrix, Inc. · Dental device
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Apr 1996
Decision
28d
Days
Class 2
Risk

K961190 is an FDA 510(k) clearance for the GLY-ETCH. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K961190

510(k) Number K961190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date April 23, 1996
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 105
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K961190.
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541 · Medental Intl. · Nov 1997
TEETHMATE F-1
K965091 · Kuraray Company, Ltd. · Mar 1997
PULPDENT SEAL-RITE UDMA
K963921 · Pulpdent Corp. · Nov 1996
IONOSIT SEAL
K954867 · Foremost Dental Mfg., Inc. · Mar 1996
SEALITE FL
K954827 · Sybron Dental Specialties, Inc. · Jan 1996
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701 · American Dental Products, Inc. · Oct 1995