Cleared Traditional

K934596 - BISCO DUO LINK D/C LUTING COMPOSITE

K934596 is the FDA 510(k) clearance for BISCO DUO LINK D/C LUTING COMPOSITE by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K934596 · Bisco, Inc. · Dental device
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Jan 1994
Decision
124d
Days
Class 2
Risk

K934596 is an FDA 510(k) clearance for the BISCO DUO LINK D/C LUTING COMPOSITE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Bisco, Inc. devices

Submission Details

510(k) Number K934596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date January 26, 1994
Days to Decision 124 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
3d faster than avg
Panel avg: 127d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K934596.
DENTIN CONDITIONING AND ADHESIVE SYSTEM
K936222 · Jeneric/Pentron, Inc. · Mar 1994
GC FUJI COAT LC
K935961 · GC America, Inc. · Mar 1994
ATTACHMENT BOND
K935735 · Heraeus Kulzer, Inc. · Mar 1994
PULPDENT DENTAL BOND ENHANCER 2-B
K931710 · Pulpdent Corp. · Aug 1993
BONDING RESIN PRODUCT LINE
K931870 · Ultradent Products, Inc. · Jul 1993
ALL-BOND(R) JR.
K932379 · Bisco, Inc. · Jul 1993