Cleared Traditional

K221152 - CuringPen Dental Curing Light

K221152 is an FDA 510(k) clearance for CuringPen Dental Curing Light, manufactured by Changzhou Sifary Medical Technology Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K221152 · Changzhou Sifary Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K221152

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.

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 88
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