Cleared Traditional

K935735 - ATTACHMENT BOND

K935735 is an FDA 510(k) clearance for ATTACHMENT BOND, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K935735 · Heraeus Kulzer, Inc. · Dental device
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Mar 1994
Decision
96d
Days
Class 2
Risk

K935735 is an FDA 510(k) clearance for the ATTACHMENT BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 96 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K935735

510(k) Number K935735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date March 07, 1994
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
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 383
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K935735.
OPTIBOND
K940513 · Kerr Corporation (Danbury) · Apr 1994
DENTIN CONDITIONING AND ADHESIVE SYSTEM
K936222 · Jeneric/Pentron, Inc. · Mar 1994
GC FUJI COAT LC
K935961 · GC America, Inc. · Mar 1994
BISCO DUO LINK D/C LUTING COMPOSITE
K934596 · Bisco, Inc. · Jan 1994
KERR OPTIBOND, MODIFICATION
K934690 · Kerr Corporation (Danbury) · Dec 1993
PULPDENT DENTAL BOND ENHANCER 2-B
K931710 · Pulpdent Corp. · Aug 1993