Cleared Special

K191221 - Cybird LED Curing Light

K191221 is an FDA 510(k) clearance for Cybird LED Curing Light, manufactured by Dxm Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Special 510(k) pathway after a 248-day FDA review.

K191221 · Dxm Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
248d
Days
Class 2
Risk

K191221 is an FDA 510(k) clearance for the Cybird LED Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dxm Co., Ltd. (Goyang-Si, KR). The FDA issued a Cleared decision on January 10, 2020 after a review of 248 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191221

510(k) Number K191221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2019
Decision Date January 10, 2020
Days to Decision 248 days
Submission Type Special
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
120d slower than avg
Panel avg: 128d · This submission: 248d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 213
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K191221.
LOOP LED Curing Light System
K200775 · Garrison Dental Solutions, LLC · Aug 2020
D-LUX+
K200809 · DiaDent Group International · Aug 2020
LED Curing Light
K192233 · Foshan Cicada Dental Instrument Co, Ltd. · Feb 2020
LED Curing Light
K192009 · Ezgo Group, Inc. · Jan 2020
SmartLite Pro Modular LED Curing Light
K191865 · Dentsply Sirona · Nov 2019
Bluephase PowerCure
K190272 · Ivoclar Vivadent, AG · Jul 2019
K191221 · Cybird LED Curing Light
Download PDF FDA Summary Dxm Co., Ltd.