Cleared Traditional

K964285 - TETRIC CERAM

K964285 is the FDA 510(k) clearance for TETRIC CERAM by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K964285 · Ivoclar North America, Inc. · Dental device
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Jan 1997
Decision
86d
Days
Class 2
Risk

K964285 is an FDA 510(k) clearance for the TETRIC CERAM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 86 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K964285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date January 22, 1997
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K964285.
FOUNDATION INDIRECT COMPOSITE RESIN
K970495 · Sybron Dental Specialties, Inc. · Apr 1997
WHITE CORE
K964931 · Bisco, Inc. · Feb 1997
ULTRA-ETCH STAT
K965060 · Ultradent Products, Inc. · Jan 1997
FIBREKOR
K964578 · Jeneric/Pentron, Inc. · Dec 1996
PRODIGY AC
K963805 · Sybron Dental Specialties, Inc. · Nov 1996
PULPDENT DESENSITIZER
K963652 · Pulpdent Corp. · Oct 1996