Cleared Traditional

K901697 - SILISTOR CERAMIC AND RESIN REPAIR SYSTEM

K901697 is an FDA 510(k) clearance for SILISTOR CERAMIC AND RESIN REPAIR SYSTEM, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K901697 · Kulzer, Inc. · Dental device
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Jun 1990
Decision
66d
Days
Class 2
Risk

K901697 is an FDA 510(k) clearance for the SILISTOR CERAMIC AND RESIN REPAIR SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 1990 after a review of 66 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K901697

510(k) Number K901697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date June 15, 1990
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 801
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K901697.
HELIO LINK (RESIN CEMENT)
K901910 · Ivoclar North America, Inc. · Jun 1990
HELIOTINT
K901918 · Ivoclar North America, Inc. · Jun 1990
SPECIAL BOND
K901916 · Ivoclar North America, Inc. · Jun 1990
EOS INLAY MATERIAL
K896469 · Ivoclar North America, Inc. · May 1990
PALFIQUE LIGHT COMPOSITE RESIN
K897010 · Tokuyama America, Inc. · May 1990
PALFIQUE LIGHT-S COMPOSITE RESIN
K897011 · Tokuyama America, Inc. · May 1990