Cleared Traditional

K901396 - CONCEPT INLAY/ONLAY

K901396 is the FDA 510(k) clearance for CONCEPT INLAY/ONLAY by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K901396 · Ivoclar North America, Inc. · Dental device
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May 1990
Decision
50d
Days
Class 2
Risk

K901396 is an FDA 510(k) clearance for the CONCEPT INLAY/ONLAY. 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 May 15, 1990 after a review of 50 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 K901396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date May 15, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
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 K901396.
SPECIAL BOND
K901916 · Ivoclar North America, Inc. · Jun 1990
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
K901697 · Kulzer, Inc. · Jun 1990
EOS INLAY MATERIAL
K896469 · Ivoclar North America, Inc. · May 1990
FERMIT TEMPORARY MATERIAL
K896530 · Ivoclar North America, Inc. · May 1990
22% POLYACRYLIC ACID GEL
K901051 · Pulpdent Corp. · Apr 1990
CORE BUILD UP COMPOSITE
K896950 · Confi-Dental Products Co. · Mar 1990