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FDA 510(k)

CuringPen Dental Curing Light

K-Number: K221152 · 2022-11-23

Decision Date2022-11-23
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CuringPen Dental Curing Light is a medical device manufactured by Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under approval number K221152. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuringPen Dental Curing Light?

CuringPen Dental Curing Light is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K221152.

When was CuringPen Dental Curing Light approved by the FDA?

CuringPen Dental Curing Light received FDA 510(k) clearance on 2022-11-23, under approval number K221152.

What company makes CuringPen Dental Curing Light?

CuringPen Dental Curing Light is manufactured by Changzhou Sifary Medical Technology Co., Ltd..

What is the FDA product code for CuringPen Dental Curing Light?

The FDA product code for CuringPen Dental Curing Light is EBZ.

Related Clinical Trials

Other Devices by Changzhou Sifary Medical Technology Co., Ltd.

Related Devices (Code: EBZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.