Cleared Traditional

K012341 - TRANSLUX ENERGY

K012341 is an FDA 510(k) clearance for TRANSLUX ENERGY, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K012341 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
37d
Days
Class 2
Risk

K012341 is an FDA 510(k) clearance for the TRANSLUX ENERGY. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 37 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K012341

510(k) Number K012341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date August 30, 2001
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
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 88
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K012341.
OPTILUX 501
K020091 · Kerr Corporation (Danbury) · Mar 2002
ASTRALIS 7, MODEL 557545
K013277 · Ivoclar Vivadent, Inc. · Oct 2001
ASTRALIS 10, MODELS # 559588, 561859
K013275 · Ivoclar Vivadent, Inc. · Oct 2001
GC E-LIGHT
K012134 · GC America, Inc. · Aug 2001
ELIPAR FREELIGHT
K011154 · Espe Dental AG · May 2001
VERSALUX
K010133 · Centrix, Inc. · Apr 2001