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ATOZ Mini-Screw

MK Meditech Inc. · Model MKS-1611 and MKS-1613 · UDI-DI 08800197900020

OAT Prescription

510(k) clearances

337

Adverse events

Recalls

Facilities

Description

DESCRIPTION The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied. INDICATION FOR USE The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment Trade Name ATOZ Mini-Screw Consist of MKS-1613*6EA + MKS-1611*2EA

Recalls

Date	Firm	Reason
2013-07-12	Ormco/Sybronendo	Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially caus
2007-09-28	Straumann USA LLC	Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
2007-09-28	Straumann USA LLC	Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

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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.