Cleared Traditional

ESPE KETAC-BOND (K844845) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 13
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K844845.
VITA Akzent LC
K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Nov 2021
Nano Varnish, Plaquit, Lightpaint on Surface
K162408 · Dreve Dentamid GmbH · Apr 2018
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
CAULK DYCAL LIGHT CURED
K850641 · Dentsply Intl. · Mar 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · Johnson & Johnson Professionals, Inc. · Feb 1985
OPAQUE COATING & SURFACE STAIN
K840751 · Dentsply Intl. · May 1984