Cleared Traditional

K910860 - ALL-BOND 2

K910860 is the FDA 510(k) clearance for ALL-BOND 2 by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K910860 · Bisco, Inc. · Dental device
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Apr 1991
Decision
68d
Days
Class 2
Risk

K910860 is an FDA 510(k) clearance for the ALL-BOND 2. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Downers Grove, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 68 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 Bisco, Inc. devices

Submission Details

510(k) Number K910860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1991
Decision Date April 29, 1991
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 K910860.
ESPE(R) -SIL
K913965 · Espe GmbH (Us) · Dec 1991
IMPERVA DUAL
K913946 · Shofu Dental Corp. · Dec 1991
PULPDENT ENAMEL BONDING AGENT
K911282 · Pulpdent Corp. · Sep 1991
ALL BOND LINER-F
K910628 · Bisco, Inc. · Mar 1991
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K904724 · Jeneric/Pentron, Inc. · Dec 1990
PERTAC UNIVERSAL BOND
K904289 · Espe GmbH (Us) · Nov 1990