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ATOZ Key
MK Meditech Inc. · Model MK Key-S · UDI-DI 08800197900693
DYJ
Prescription
5
510(k) clearances
86
Adverse events
6
Recalls
119
Facilities
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)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 2014-02-24 | Allesee Orthodontic Appliances | The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar |
| 2013-06-06 | Sybron Dental Specialties | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Meta |
| 2009-10-02 | Ormco Corporation | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection fro |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.