Cleared Traditional

CuringPen Dental Curing Light (K221152) - FDA 510(k) Clearance

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

K221152 · Changzhou Sifary Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Nov 2022
Decision
217d
Days
Class 2
Risk

K221152 is an FDA 510(k) clearance for the CuringPen Dental Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Changzhou Sifary Medical Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on November 23, 2022 after a review of 217 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 Changzhou Sifary Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K221152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2022
Decision Date November 23, 2022
Days to Decision 217 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
90d slower than avg
Panel avg: 127d · This submission: 217d
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 Peers - EBZ Activator, Ultraviolet, For Polymerization

All 42
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K221152.
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
K223507 · Good Doctors Co., Ltd. · Aug 2023
Coltolux Comfort LED Curing Light
K223142 · Dent4you AG · Dec 2022
LED Curing Light
K220826 · Foshan Coxo Medical Instrument Co., Ltd. · Dec 2022
LEDEX
K221194 · Dentmate Technology Co. , Ltd. · Sep 2022
VALO X, VALO X Accessory Lenses
K220471 · Ultradent Products, Inc. · Feb 2022
VALO Grand Corded and Accessory Lenses
K210550 · Ultradent Products, Inc. · Mar 2021