ATOZ Expander Kit

FDA UDI

Class I (US FDA UDI)

by M.K. Meditech Co. , Ltd.

Identity

Trade Name: ATOZ Expander Kit FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea FDA UDI
Model / Reference: ATOZ Expander Kit FDA UDI
Description: The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea FDA UDI

Identifiers

Primary DI / UDI-DI: 08800197900341 FDA UDI
FDA Product Code: DYJ FDA UDI
OAT FDA UDI
DZC FDA UDI
NDP FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
872.3640 FDA UDI
872.3980 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

MRI Safety

MR Unsafe FDA UDI

Category: Orthodontic archwire Surgical screwdriver, reusable Orthodontic anchoring screw Orthodontic palate expander/teeth aligner, bonded

ATOZ Expander Kit 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 palate expander screw key.

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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 b5cd9ca0-ba2e-4d6c-9641-0bbb2c4e1e96 33 fields · synced May 30, 2026