Cleared Traditional

K896530 - FERMIT TEMPORARY MATERIAL

K896530 is the FDA 510(k) clearance for FERMIT TEMPORARY MATERIAL by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K896530 · Ivoclar North America, Inc. · Dental device
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May 1990
Decision
174d
Days
Class 2
Risk

K896530 is an FDA 510(k) clearance for the FERMIT TEMPORARY MATERIAL. 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 7, 1990 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K896530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date May 07, 1990
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
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 K896530.
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
K901697 · Kulzer, Inc. · Jun 1990
EOS INLAY MATERIAL
K896469 · Ivoclar North America, Inc. · May 1990
CONCEPT INLAY/ONLAY
K901396 · 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
SEPARATING MEDIUM (POLYVINYL ALCOHOL)
K896653 · Pulpdent Corp. · Feb 1990