Cleared Traditional

SILICOATER SYSTEM (K915335) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915335 · Heraeus Kulzer, Inc. · Dental device
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Jan 1992
Decision
56d
Days
Class 2
Risk

K915335 is an FDA 510(k) clearance for the SILICOATER SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on January 21, 1992 after a review of 56 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K915335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date January 21, 1992
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 208
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K915335.
DENTACOLOR(R) CRE-ACTIVE
K914456 · Heraeus Kulzer, Inc. · Mar 1992
TWINLOOK
K915336 · Heraeus Kulzer, Inc. · Feb 1992
ADS-GEL AND INSULATING-GEL
K915355 · Heraeus Kulzer, Inc. · Jan 1992
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991
DENTAL CORE MATERIAL
K896564 · Dentsply Intl. · Feb 1990
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987