Cleared Traditional

K962733 - CYBER-FIL ALKENOATE CEMENT MULTI-PURPOS...

K962733 is the FDA 510(k) clearance for CYBER-FIL ALKENOATE CEMENT MULTI-PURPOS... by Union Broach, Div. Moyco Industries, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K962733 · Union Broach, Div. Moyco Industries, Inc. · Dental device
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Oct 1996
Decision
88d
Days
Class 2
Risk

K962733 is an FDA 510(k) clearance for the CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Union Broach, Div. Moyco Industries, Inc. (York, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 88 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 Union Broach, Div. Moyco Industries, Inc. devices

Submission Details

510(k) Number K962733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date October 11, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 296
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K962733.
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