ATOZ Key

GUDID 08800197900082

DESCRIPTION This is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USE This is a product to expand the ATOZ expander. TRADE NAME ATOZ Key MODEL NUMBER Longer key (MK Key-L), Shorter key (MK Key-S)

MK Meditech Inc.

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Primary Device ID08800197900082
NIH Device Record Keyef6b1e58-b5c0-44ea-a10a-be77c2497fe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameATOZ Key
Version Model NumberMK Key-L and MK Key-S
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800197900082 [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 Date2022-01-31
Device Publish Date2022-01-22

Devices Manufactured by MK Meditech Inc.

08800197900198 - ATOZ Mini-Screw2024-01-22 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
08800197900358 - ATOZ Expander2024-01-22 The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch.
08800197900334 - ATOZ Mini-Screw2023-10-23 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
08800197900341 - ATOZ Expander Kit2023-10-23 The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and
08800197900327 - MK Drill Bit2023-09-06 The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is use
08800197900280 - MK Drill Bit2023-08-30 MKDB-DG-08 * 10EA
08800197900303 - ATOZ Mini-Screw2023-07-27 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
08800197900297 - ATOZ Mini-Screw2023-07-26 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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