Cleared Traditional

K083652 - IBOND TOTAL ETCH

K083652 is an FDA 510(k) clearance for IBOND TOTAL ETCH, 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 43-day FDA review.

K083652 · Heraeus Kulzer,GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
43d
Days
Class 2
Risk

K083652 is an FDA 510(k) clearance for the IBOND TOTAL ETCH. 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 January 21, 2009 after a review of 43 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 - K083652

510(k) Number K083652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date January 21, 2009
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
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 K083652.
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K091300 · CAO Group, Inc. · Jul 2009
ADHESE ONE F
K090941 · Ivoclar Vivadent, Inc. · Jul 2009
MONOBOND PLUS
K090826 · Ivoclar Vivadent, Inc. · May 2009
BEAUTIBOND
K082744 · Shofu Dental Corp. · Dec 2008
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · Voco GmbH · Nov 2008
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008