Cleared Traditional

K921701 - DURAFILL BOND

K921701 is the FDA 510(k) clearance for DURAFILL BOND by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K921701 · Heraeus Kulzer, Inc. · Dental device
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Jun 1992
Decision
62d
Days
Class 2
Risk

K921701 is an FDA 510(k) clearance for the DURAFILL 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 June 9, 1992 after a review of 62 days - a notably fast clearance cycle.

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: 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 K921701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date June 09, 1992
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
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 297
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K921701.
POLIBOND
K924181 · Voco GmbH · Oct 1992
OPTIBOND
K923546 · Kerr Corporation (Danbury) · Sep 1992
BISCO UNIVERSAL BOND-3
K923842 · Bisco, Inc. · Sep 1992
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
SR-ISOSIT SPECTRA LINK SYSTEM
K910069 · Ivoclar North America, Inc. · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992