Identity
- Trade Name
- ATOZ Expander FDA UDI
- Generic Name
- Orthodontic palate expander/teeth aligner, bonded FDA UDI
- Device Name
- 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 USE The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch Trade Name: ATOZ Expander Model Number: A-UNI-F08 FDA UDI
- Model / Reference
- A-UNI-F08 FDA UDI
- Description
- 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 USE The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch Trade Name: ATOZ Expander Model Number: A-UNI-F08 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800197900372 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic palate expander/teeth aligner, bonded 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic palate expander/teeth aligner, bonded
ATOZ Expander 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 7e065cad-da5f-4c07-bd03-51907787adf8 33 fields · synced May 30, 2026