Model ATOZ

GUDID 08800197900549

DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide to hold the real ATOZ Expander in place on the palate during the anchoring screw placement. The Model ATOZ is used for making a surgical guide for ATOZ Expander. INDICATION FOR USE The Model ATOZ is used for making a surgical guide for the ATOZ Expander. TRADE NAME Model ATOZ MODEL NUMBER Model ATOZ-A-UNI-F08

MK Meditech Inc.

Orthodontic retainer support kit
Primary Device ID08800197900549
NIH Device Record Key96a6a1c4-8d7d-42ed-9750-8237d2f1c6b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel ATOZ
Version Model NumberModel ATOZ-A-UNI-F08
Company DUNS695009476
Company NameMK Meditech Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800197900549 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-03
Device Publish Date2024-12-26

Devices Manufactured by MK Meditech Inc.

08800197900396 - ATOZ Utility Wire2025-01-06 PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and mol
08800197900389 - Guide ATOZ2025-01-03 DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensur
08800197900549 - Model ATOZ2025-01-03 DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide to hold the real ATOZ Expander in place on the palate during the anchoring screw placement. The Model ATOZ is used for making a surgical guide for ATOZ Expander. INDICATION FOR USE The Model ATOZ is used for making a surgical guide for the ATOZ Expander. TRADE NAME Model ATOZ MODEL NUMBER Model ATOZ-A-UNI-F08
08800197900549 - Model ATOZ2025-01-03 DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide t
08800197900556 - ATOZ Screwdriver2024-12-31 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 Screwdriver2024-12-31 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 Key2024-12-31 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-Screw2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
08800197900648 - ATOZ Mini-Screw2024-12-26 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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