Cleared Traditional

K844845 - ESPE KETAC-BOND

K844845 is the FDA 510(k) clearance for ESPE KETAC-BOND by Espe GmbH (Us). It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 33
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K844845.
UNINHIBITED
K021503 · Bisco, Inc. · Aug 2002
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 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