Cleared Traditional

K170529 - Delight

K170529 is an FDA 510(k) clearance for Delight, manufactured by Dentall Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K170529 · Dentall Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
167d
Days
Class 2
Risk

K170529 is an FDA 510(k) clearance for the Delight, Delight ortho, B&Lite S. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentall Co., Ltd. (Bucheon-Si, KR). The FDA issued a Cleared decision on August 8, 2017 after a review of 167 days - an extended review 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: 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 Dentall Co., Ltd. devices

FDA 510(k) Submission Details - K170529

510(k) Number K170529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date August 08, 2017
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
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 98
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K170529.
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