Cleared Traditional

K223414 - Curing Light, Model: MaxCure 9 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223414 · Guilin Refine Medical Instrument Co., Ltd. · Dental device
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Nov 2023
Decision
370d
Days
Class 2
Risk

K223414 is an FDA 510(k) clearance for the Curing Light, Model: MaxCure 9. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Guilin Refine Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on November 15, 2023 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Guilin Refine Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K223414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2022
Decision Date November 15, 2023
Days to Decision 370 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
243d slower than avg
Panel avg: 127d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

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 212
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K223414.
Demi Pro
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K250009 · Premium Plus (Dongguan) Limited · Apr 2025
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