| Primary Device ID | 08800197900396 |
| NIH Device Record Key | 8f22c3f8-6ccf-448d-af9c-d9d56fbfbf5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATOZ Utility Wire |
| Version Model Number | MK Wire arm-1260 * 4EA |
| Company DUNS | 695009476 |
| Company Name | MK Meditech Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800197900396 [Primary] |
| DZC | Wire, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
[08800197900396]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-06 |
| Device Publish Date | 2024-12-27 |
| 08800197900396 - ATOZ Utility Wire | 2025-01-06PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement. TRADE NAME ATOZ Utility Wire MODEL NAME MK Wire arm-1260 INDICATION FOR USE This can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan. PRODUCT MATERIAL 316 Stainless Steel CONSIST OF: MK Wire arm-1260*4ea |
| 08800197900396 - ATOZ Utility Wire | 2025-01-06 PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and mol |
| 08800197900389 - Guide ATOZ | 2025-01-03 DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensur |
| 08800197900549 - Model ATOZ | 2025-01-03 DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide t |
| 08800197900556 - ATOZ Screwdriver | 2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK |
| 08800197900563 - ATOZ Screwdriver | 2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK |
| 08800197900693 - ATOZ Key | 2024-12-31 DESCRIPTION This is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside t |
| 08800197900631 - ATOZ Mini-Screw | 2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the |
| 08800197900648 - ATOZ Mini-Screw | 2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the |