Cleared Traditional

K892455 - KULZER ADHESIVE CEMENT

K892455 is an FDA 510(k) clearance for KULZER ADHESIVE CEMENT, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K892455 · Kulzer, Inc. · Dental device
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Jun 1989
Decision
73d
Days
Class 2
Risk

K892455 is an FDA 510(k) clearance for the KULZER ADHESIVE CEMENT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K892455

510(k) Number K892455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date June 22, 1989
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 801
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K892455.
TOOTH SHADE RESIN
K895976 · G-C Intl. Corp. · Dec 1989
CRYSTALLINE C2 AND CRYSTALLINE L3
K894890 · Confi-Dental Products Co. · Oct 1989
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
K894644 · Jeneric/Pentron, Inc. · Oct 1989
KULZER INLAY SYSTEM
K892454 · Kulzer, Inc. · Jun 1989
ESPE TULUX-CEM
K891020 · Espe GmbH (Us) · May 1989
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
K891463 · Confi-Dental Products Co. · May 1989