Cleared Traditional

K844845 - ESPE KETAC-BOND

K844845 is an FDA 510(k) clearance for ESPE KETAC-BOND, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K844845 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
249d
Days
Class 2
Risk

K844845 is an FDA 510(k) clearance for the ESPE KETAC-BOND. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 249 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Espe GmbH (Us) devices

FDA 510(k) Submission Details - K844845

510(k) Number K844845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date August 19, 1985
Days to Decision 249 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 127d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 45
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K844845.
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · Austenal Dental, Inc. · Jan 1986
CURAY JOIN DENT DENTIN PRIMER
K850675 · Scientific Pharmaceuticals, Inc. · Mar 1985
CAULK DYCAL LIGHT CURED
K850641 · Dentsply Intl. · Mar 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · Johnson & Johnson Professionals, Inc. · Feb 1985