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Arch Alexand Tma Lo Sml 019x025 Pk/10

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 207-0061

by Ormco Corporation

Identity

Trade Name
ARCH ALEXAND TMA LO SML 019X025 PK/10 EUDAMED
Vari-Simplex - TMA FDA UDI
Generic Name
Orthodontic archwire FDA UDI
Device Name
ARCH ALEXAND TMA LO SML 019X025 PK/10 EUDAMEDFDA UDI
Model / Reference
207-0061 EUDAMEDFDA UDI
Description
ARCH ALEXAND TMA LO SML 019X025 PK/10 FDA UDI

Identifiers

Primary DI / UDI-DI
00889989026641 EUDAMEDFDA UDI
Basic UDI-DI
B-00889989026641 EUDAMED
FDA Product Code
DZC FDA UDI
EMDN Code
Q010405 ORTHODONTIC WIRES EUDAMED
GMDN Term
Orthodontic archwire FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.5410 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The ARCH ALEXAND TMA LO SML 019X025 PK/10 medical device is a Class IIa instrument designed for use in the temporary replacement of certain teeth. This device meets the standards and specifications outlined in regulatory requirements such as FDA 510(k) clearance, ISO 60601-1, and CE marking.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ormco Corporation
EUDAMED SRN
US-MF-000038085
Authorised Representative
KERR ITALIA SRL IT-AR-000007600

Sources (2)

  • EUDAMED 87f79458-3ba0-41bc-92c4-2bbf11dcb0c3 61 fields · synced Jul 17, 2026
  • FDA UDI 5956e875-bad2-4c74-bd9c-58d7789884b3 35 fields · synced May 30, 2026