Cleared Traditional

K892517 - TULUX-FILTER

K892517 is the FDA 510(k) clearance for TULUX-FILTER by Espe GmbH (Us). It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K892517 · Espe GmbH (Us) · Dental device
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Aug 1989
Decision
132d
Days
Class 2
Risk

K892517 is an FDA 510(k) clearance for the TULUX-FILTER. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K892517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date August 21, 1989
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 79
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K892517.
HELIOLUX
K913980 · Ivoclar North America, Inc. · Dec 1991
SPECTRAMAT
K910068 · Ivoclar North America, Inc. · Mar 1991
HELIOLUX VISIBLE CURING LIGHT
K901908 · Ivoclar North America, Inc. · Jul 1990
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
TRANSLUX CL
K843823 · Kulzer, Inc. · Dec 1984