ATOZ-Tooth Connection Arms

GUDID 08800197900044

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 Wire arm MODEL NAME MK Wire arm-1240 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 316L Stainless Steel CONSIST OF: MK-Wire arm-1240*4ea

MK Meditech Inc.

Orthodontic archwire

Primary Device ID	08800197900044
NIH Device Record Key	cdb65944-1dd3-4a61-9b86-63166e9e584b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ATOZ-Tooth Connection Arms
Version Model Number	MK-Wire arm-1240
Company DUNS	695009476
Company Name	MK Meditech Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800197900044 [Primary]

FDA Product Code

DZC	Wire, Orthodontic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

[08800197900044]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-31
Device Publish Date	2022-01-22

Devices Manufactured by MK Meditech Inc.

08800197900396 - ATOZ Utility Wire	2025-01-06 PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and mol
08800197900389 - Guide ATOZ	2025-01-03 DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensur
08800197900549 - Model ATOZ	2025-01-03 DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide t
08800197900556 - ATOZ Screwdriver	2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK
08800197900563 - ATOZ Screwdriver	2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK
08800197900693 - ATOZ Key	2024-12-31 DESCRIPTION This is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside t
08800197900631 - ATOZ Mini-Screw	2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
08800197900648 - ATOZ Mini-Screw	2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the

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