Cleared Traditional

K874788 - KETAC-BOND APLICAP

K874788 is an FDA 510(k) clearance for KETAC-BOND APLICAP, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K874788 · Espe GmbH (Us) · Dental device
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Apr 1988
Decision
141d
Days
Class 2
Risk

K874788 is an FDA 510(k) clearance for the KETAC-BOND APLICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 - K874788

510(k) Number K874788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1987
Decision Date April 12, 1988
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K874788.
KERR XR IONOMER
K880251 · Kerr Corporation (Danbury) · Jun 1988
FUJI CAP II CAPSULE & APPLIER
K880848 · G-C Intl. Corp. · May 1988
PORCELITE DUAL CURE CEMENT
K880685 · Kerr Corporation (Danbury) · May 1988
KETAC-CONDITIONER
K872984 · Espe GmbH (Us) · Mar 1988
CEMENT LINER
K874945 · Dentsply Intl. · Feb 1988
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K874500 · Harry J. Bosworth Co. · Feb 1988