Cleared Traditional

K892453 - KULZER GLAS-IONOMER CEMENT

K892453 is an FDA 510(k) clearance for KULZER GLAS-IONOMER CEMENT, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K892453 · Kulzer, Inc. · Dental device
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Dec 1989
Decision
238d
Days
Class 2
Risk

K892453 is an FDA 510(k) clearance for the KULZER GLAS-IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 238 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K892453

510(k) Number K892453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date December 04, 1989
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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 K892453.
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
K894477 · Cosmedent, Inc. · Jan 1990
SILCOT COPAL CAVITY VARNISH
K895798 · Specialites Septodont · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · Specialites Septodont · Mar 1989
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988