Cleared Traditional

K934596 - BISCO DUO LINK D/C LUTING COMPOSITE

K934596 is an FDA 510(k) clearance for BISCO DUO LINK D/C LUTING COMPOSITE, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K934596

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.

KLE Device Classification - Class 2, Special Controls

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 371
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
KERR OPTIBOND, MODIFICATION
K934690 · Kerr Corporation (Danbury) · Dec 1993
PULPDENT DENTAL BOND ENHANCER 2-B
K931710 · Pulpdent Corp. · Aug 1993
BONDING RESIN PRODUCT LINE
K931870 · Ultradent Products, Inc. · Jul 1993