Cleared Traditional

K963311 - TEAM ETCH

K963311 is the FDA 510(k) clearance for TEAM ETCH by Centrix, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K963311 · Centrix, Inc. · Dental device
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Oct 1996
Decision
46d
Days
Class 2
Risk

K963311 is an FDA 510(k) clearance for the TEAM ETCH. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Centrix, Inc. devices

Submission Details

510(k) Number K963311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1996
Decision Date October 07, 1996
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.

Device Classification

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 578
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K963311.
FIBREKOR
K964578 · Jeneric/Pentron, Inc. · Dec 1996
PRODIGY AC
K963805 · Sybron Dental Specialties, Inc. · Nov 1996
PULPDENT DESENSITIZER
K963652 · Pulpdent Corp. · Oct 1996
TARGIS SYSTEM
K962878 · Ivoclar North America, Inc. · Sep 1996
VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
K961434 · Vident · Jul 1996
CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
K960667 · Wallace A. Erickson & Co. · Jul 1996