Cleared Traditional

K911061 - ESPE KETAC-ENDO APLICAP

K911061 is an FDA 510(k) clearance for ESPE KETAC-ENDO APLICAP, manufactured by H.A. Opotow Consulting. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K911061 · H.A. Opotow Consulting · Dental device
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Jan 1992
Decision
298d
Days
Class 2
Risk

K911061 is an FDA 510(k) clearance for the ESPE KETAC-ENDO APLICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by H.A. Opotow Consulting (Lake Worth, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 298 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 H.A. Opotow Consulting devices

FDA 510(k) Submission Details - K911061

510(k) Number K911061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date January 03, 1992
Days to Decision 298 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 127d · This submission: 298d
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 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K911061.
MERON DENTAL CEMENT
K914612 · Voco GmbH · Feb 1992
CIMPAT S DENTAL CEMENT
K915467 · Specialites Septodont · Feb 1992
PHOTAC-BOND APLICAP, MODIFICATION
K915005 · Espe GmbH (Us) · Jan 1992
CAVITY VARNISH PRODUCT
K914324 · Confi-Dental Products Co. · Dec 1991
FUJI II LC
K913884 · G-C Intl. Corp. · Oct 1991
F21(R) DENTAL CEMENT
K914073 · Voco GmbH · Oct 1991