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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 the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) 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. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K221152.

When did CuringPen Dental Curing Light receive FDA 510(k) clearance?

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

Who is the listed applicant for CuringPen Dental Curing Light?

The FDA 510(k) record lists Changzhou Sifary Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Changzhou Sifary Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.