Identity
- Trade Name
- ATOZ Expander Kit FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- ATOZ Expander Kit *10SET FDA UDI
- Model / Reference
- ATOZ Expander Kit*10SET FDA UDI
- Description
- ATOZ Expander Kit *10SET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800197900075 FDA UDI
- FDA Product Code
- DYJ FDA UDIOAT FDA UDIDZC FDA UDINDP FDA UDI
- GMDN Term
- Orthodontic palate expander screw key FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI872.3640 FDA UDI872.3980 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic archwireSurgical screwdriver, reusableOrthodontic anchoring screwOrthodontic palate expander/teeth aligner, bonded
ATOZ Expander Kit by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ca2deed9-b059-42ca-981b-5f1b5868e127 33 fields · synced May 30, 2026