Cleared Traditional

K962428 - EBS (ESPE BONDING SYSTEM)

K962428 is an FDA 510(k) clearance for EBS (ESPE BONDING SYSTEM), manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K962428 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
80d
Days
Class 2
Risk

K962428 is an FDA 510(k) clearance for the EBS (ESPE BONDING SYSTEM). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on September 12, 1996 after a review of 80 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 Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K962428

510(k) Number K962428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1996
Decision Date September 12, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
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 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K962428.
BISFIL 2B
K964000 · Bisco, Inc. · Nov 1996
GLUMA CONDITIONER
K964140 · Heraeus Kulzer, Inc. · Nov 1996
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K962812 · Heraeus Kulzer, Inc. · Oct 1996
3M DENT SYSTEM
K962785 · 3M Company · Aug 1996
KERR ADVANCED ADHESIVE
K962515 · Kerr Dental Materials Center · Aug 1996
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
K960696 · Ultradent Products, Inc. · Jul 1996