Cleared Traditional

K960954 - KETAC-MOLAR APLICAP

K960954 is an FDA 510(k) clearance for KETAC-MOLAR APLICAP, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K960954 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
66d
Days
Class 2
Risk

K960954 is an FDA 510(k) clearance for the KETAC-MOLAR APLICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on May 16, 1996 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K960954

510(k) Number K960954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date May 16, 1996
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
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 366
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K960954.
VIVAGLASS FIL
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K961584 · GC America, Inc. · May 1996
C & B METABOND (MODIFICATION)
K960464 · Parkell, Inc. · Feb 1996
ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
K955089 · Wallace A. Erickson & Co. · Dec 1995
OPTIBOND 2A PRECOAT
K955068 · Sybron Dental Specialties, Inc. · Dec 1995