Cleared Traditional

K955759 - LITEX 680

K955759 is an FDA 510(k) clearance for LITEX 680, manufactured by Dentamerica. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K955759 · Dentamerica · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
15d
Days
Class 2
Risk

K955759 is an FDA 510(k) clearance for the LITEX 680. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentamerica (Industry, US). The FDA issued a Cleared decision on January 2, 1996 after a review of 15 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.

FDA 510(k) Submission Details - K955759

510(k) Number K955759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date January 02, 1996
Days to Decision 15 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
113d faster than avg
Panel avg: 128d · This submission: 15d
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 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K955759.
CU-200 LIGHT CURE UNIT
K960364 · Rolence Enterprise Co. , Ltd. · Apr 1996
ACL-5500 PRECISION CURING UNIT (PCU)
K953898 · Ion Laser Technology · Feb 1996
OPTILUX 400
K955763 · Demetron Research Corp. · Jan 1996
POLY-LITE MODEL 1000
K954061 · Pro-Den Systems, Inc. · Sep 1995
CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676
K952423 · Rolence Enterprise Co. , Ltd. · Jun 1995
SUNLITE 1275
K951465 · Fen Dental Mfg., Inc. · May 1995
K955759 · LITEX 680
Download PDF FDA Summary Dentamerica