Cleared Traditional

K072480 - GENERATION 8 SE ADHESIVE

K072480 is an FDA 510(k) clearance for GENERATION 8 SE ADHESIVE, manufactured by Pentron Clinical Technologies. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K072480 · Pentron Clinical Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
78d
Days
Class 2
Risk

K072480 is an FDA 510(k) clearance for the GENERATION 8 SE ADHESIVE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 78 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 Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K072480

510(k) Number K072480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date November 21, 2007
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K072480.
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
RELIANCE S.E.P.
K071688 · Reliance Orthodontic Products, Inc. · Sep 2007
UNO
K071131 · 3M Espe AG Dental Products · Jul 2007
HERMES BOND 3
K071260 · 3M Espe AG Dental Products · Jul 2007