ATOZ Expander - The ATOZ Expander is used to stretch and split - MK Meditech Inc.

Duns Number:695009476

Device Description: The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently inc The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch.For the procedure, the ATOZ Expander is placed under the patient's palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient's palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient's palate is sufficiently wide.INDICATION FOR USEThe ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary archTrade Name: ATOZ ExpanderModel Number: MKE-08-F

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More Product Details

Catalog Number

-

Brand Name

ATOZ Expander

Version/Model Number

MKE-08-F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DYJ

Product Code Name

Retainer, Screw Expansion, Orthodontic

Device Record Status

Public Device Record Key

b7c31119-9555-43c0-aa73-1f25ac527a33

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MK MEDITECH INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 6