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CuringPen

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref 6580001Model CuringPen, KIRA, Lumina Smart510(k) K221152Ref 6580041Model CuringPen-E

by Changzhou Sifary Medical Technology Co., Ltd.

Identity

Trade Name
CuringPen EUDAMED
CuringPen-E EUDAMED
Device Name
Dental Curing Light EUDAMED
Model / Reference
CuringPen, KIRA, Lumina Smart EUDAMED
6580001 EUDAMED
CuringPen-E EUDAMED
6580041 EUDAMED

Identifiers

Primary DI / UDI-DI
06972597780099 EUDAMED
06941877800024 EUDAMED
Basic UDI-DI
697259778EL001M9 EUDAMED
697259778EL002MB EUDAMED
510(k) Number
K221152 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)
EMDN Code
Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Market of Registration
Poland EUDAMED
Latvia EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

CuringPen by Changzhou Sifary Medical Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Changzhou Sifary Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010405
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (3)

  • EUDAMED b05943ea-f5db-401f-b5a0-9f60b77dd890 61 fields · synced Jul 11, 2026
  • FDA 510(k) K221152 24 fields · synced May 18, 2026
  • EUDAMED 5cbb270b-0e23-4e6d-8ebc-befb66a717fc 61 fields · synced Jul 11, 2026