Cleared Traditional

K900135 - CU-75 VISIBLE LIGHT-CURING UNIT

K900135 is an FDA 510(k) clearance for CU-75 VISIBLE LIGHT-CURING UNIT, manufactured by Kab Gloves Unltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K900135 · Kab Gloves Unltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
117d
Days
Class 2
Risk

K900135 is an FDA 510(k) clearance for the CU-75 VISIBLE LIGHT-CURING UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kab Gloves Unltd. (Berkley, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 117 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 Kab Gloves Unltd. devices

FDA 510(k) Submission Details - K900135

510(k) Number K900135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1990
Decision Date May 07, 1990
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K900135.
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
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988