ATOZ Utility Wire

FDA UDI

Class I (US FDA UDI)

by M.K. Meditech Co. , Ltd.

Identity

Trade Name: ATOZ Utility Wire FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement. TRADE NAME ATOZ Utility Wire MODEL NAME MK Wire arm-1260 INDICATION FOR USE This can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan. PRODUCT MATERIAL 316 Stainless Steel CONSIST OF: MK Wire arm-1260*4ea FDA UDI
Model / Reference: MK Wire arm-1260 * 4EA FDA UDI
Description: PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement. TRADE NAME ATOZ Utility Wire MODEL NAME MK Wire arm-1260 INDICATION FOR USE This can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan. PRODUCT MATERIAL 316 Stainless Steel CONSIST OF: MK Wire arm-1260*4ea FDA UDI

Identifiers

Primary DI / UDI-DI: 08800197900396 FDA UDI
FDA Product Code: DZC FDA UDI
GMDN Term: Orthodontic archwire FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic archwire

ATOZ Utility Wire by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic archwire.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: M.K. Meditech Co. , Ltd.

Sources (1)

FDA UDI 8f22c3f8-6ccf-448d-af9c-d9d56fbfbf5b 33 fields · synced Jun 8, 2026