Cleared Traditional

K872984 - KETAC-CONDITIONER

K872984 is an FDA 510(k) clearance for KETAC-CONDITIONER, 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 222-day FDA review.

K872984 · Espe GmbH (Us) · Dental device
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Mar 1988
Decision
222d
Days
Class 2
Risk

K872984 is an FDA 510(k) clearance for the KETAC-CONDITIONER. 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 March 9, 1988 after a review of 222 days - an extended review cycle.

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 - K872984

510(k) Number K872984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1987
Decision Date March 09, 1988
Days to Decision 222 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
95d slower than avg
Panel avg: 127d · This submission: 222d
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 K872984.
FUJI CAP II CAPSULE & APPLIER
K880848 · G-C Intl. Corp. · May 1988
PORCELITE DUAL CURE CEMENT
K880685 · Kerr Corporation (Danbury) · May 1988
KETAC-BOND APLICAP
K874788 · Espe GmbH (Us) · Apr 1988
CEMENT LINER
K874945 · Dentsply Intl. · Feb 1988
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K874500 · Harry J. Bosworth Co. · Feb 1988
INSURE PORCELAIN VENEER BONDING SYSTEM
K873356 · Cosmedent, Inc. · Dec 1987