Cleared Traditional

K843823 - TRANSLUX CL

K843823 is an FDA 510(k) clearance for TRANSLUX CL, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K843823 · Kulzer, Inc. · Dental device
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Dec 1984
Decision
67d
Days
Class 2
Risk

K843823 is an FDA 510(k) clearance for the TRANSLUX CL. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 67 days - a notably fast clearance cycle.

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: 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 - K843823

510(k) Number K843823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date December 04, 1984
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
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 161
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K843823.
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · Unitek Corp. · Apr 1988
OP II VISIBLE LIGHT CURING SYSTEM
K854696 · Almore Intl., Inc. · Mar 1986
COE-LITE POLYMERIZATION UNIT
K844325 · Coe Laboratories, Inc. · Dec 1984
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · Kulzer, Inc. · Jul 1981
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980