Cleared Traditional

K970506 - HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT

K970506 is an FDA 510(k) clearance for HILUX 200, manufactured by Benlioglu Dental Ithalat, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K970506 · Benlioglu Dental Ithalat, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
114d
Days
Class 2
Risk

K970506 is an FDA 510(k) clearance for the HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Benlioglu Dental Ithalat, Inc. (Ankara, TR). The FDA issued a Cleared decision on June 4, 1997 after a review of 114 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 Benlioglu Dental Ithalat, Inc. devices

FDA 510(k) Submission Details - K970506

510(k) Number K970506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date June 04, 1997
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
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 103
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