Cleared Traditional

K070646 - ADHESE ONE

K070646 is the FDA 510(k) clearance for ADHESE ONE by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K070646 · Ivoclar Vivadent, Inc. · Dental device
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May 2007
Decision
64d
Days
Class 2
Risk

K070646 is an FDA 510(k) clearance for the ADHESE ONE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 64 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K070646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2007
Decision Date May 11, 2007
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
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 K070646.
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008
FL BOND II
K071452 · Shofu Dental Corp. · Jul 2007
FUTURABOND DC/SINGLE DOSE
K070723 · Voco GmbH · Jun 2007
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · Dentsply Intl. · Mar 2007
ACE BOND SE
K063780 · Bisco, Inc. · Jan 2007
PEAK SE, MODEL 5135
K063558 · Ultradent Products, Inc. · Dec 2006