Cleared Traditional

K963737 - HYCEM APLICAP

K963737 is an FDA 510(k) clearance for HYCEM 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 59-day FDA review.

K963737 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
59d
Days
Class 2
Risk

K963737 is an FDA 510(k) clearance for the HYCEM 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 November 15, 1996 after a review of 59 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 - K963737

510(k) Number K963737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date November 15, 1996
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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 K963737.
HI DENSE TC
K971927 · Shofu Dental Corp. · Jun 1997
SPETEMP
K964808 · Ultradent Products, Inc. · Feb 1997
SPETEMP EF
K964809 · Ultradent Products, Inc. · Jan 1997
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · Pulpdent Corp. · Sep 1996
STERI-OSS TEMPORARY IMPLANT CEMENT
K963078 · Steri-Oss, Inc. · Sep 1996
PULPDENT RESILUTE II
K962383 · Pulpdent Corp. · Sep 1996