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ATOZ Expander

MK Meditech Inc. · Model A-UNI-F08 · UDI-DI 08800197900372

DYJ Prescription

510(k) clearances

Adverse events

Recalls

119

Facilities

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

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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Data 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.