Cleared Traditional

K051006 - IBOND NEXT GENERATION

K051006 is an FDA 510(k) clearance for IBOND NEXT GENERATION, manufactured by Heraeus Kulzer,GmbH. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K051006 · Heraeus Kulzer,GmbH · Dental device
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Jun 2005
Decision
48d
Days
Class 2
Risk

K051006 is an FDA 510(k) clearance for the IBOND NEXT GENERATION. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 48 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,GmbH devices

FDA 510(k) Submission Details - K051006

510(k) Number K051006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date June 07, 2005
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 347
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K051006.
MULTIPLE RESIN TOOTH BONDING AGENT
K052501 · Cosmedent, Inc. · Oct 2005
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
ALL-IN-ONE
K050647 · Bisco, Inc. · Apr 2005
ADHESIVE 1
K050331 · Southern Dental Industries, Inc. · Mar 2005
BOSWORTH BOND
K043170 · Harry J. Bosworth Co. · Feb 2005