Identity
- Trade Name
- Guide ATOZ FDA UDI
- Generic Name
- Orthodontic retainer support kit FDA UDI
- Device Name
- DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensure the correct orientation of the ATOZ Drill Bit or ATOZ screwdriver, facilitating the smooth placement of ATOZ Mini-Screws INDICATION FOR USE The Guide ATOZ is used to assist in the process of installing the ATOZ Expander. TRADE NAME Guide ATOZ MODEL NUMBER MK-G-08 FDA UDI
- Model / Reference
- MK-G-08 FDA UDI
- Description
- DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensure the correct orientation of the ATOZ Drill Bit or ATOZ screwdriver, facilitating the smooth placement of ATOZ Mini-Screws INDICATION FOR USE The Guide ATOZ is used to assist in the process of installing the ATOZ Expander. TRADE NAME Guide ATOZ MODEL NUMBER MK-G-08 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800197900389 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic retainer support kit 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
No
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 retainer support kit
Guide ATOZ by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic retainer support kit.
- Chewies — STRAIGHT SMILE LLC · Class I
- SureSmile® — Dentsply Sirona Orthodontics Inc. · Class I
- Model ATOZ — 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 fca5103d-889e-4c45-8802-9432a2d21a6c 33 fields · synced May 30, 2026