Identity
- Trade Name
- ATOZ Key FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- 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 Shorter key (MK Key-S) FDA UDI
- Model / Reference
- MK Key-S FDA UDI
- Description
- 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 Shorter key (MK Key-S) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800197900693 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic palate expander screw key FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic palate expander screw key
ATOZ Key by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ATOZ Expander Kit — M.K. Meditech Co. , Ltd. · Class I
- ATOZ Expander Kit — M.K. Meditech Co. , Ltd. · Class I
- ATOZ Key — M.K. Meditech Co. , Ltd. · Class I
- ATOZ Expander Kit — M.K. Meditech Co. , Ltd. · Class I
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 5c8588d7-67e4-48a4-90b2-d98194224dac 33 fields · synced May 30, 2026