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OBS Anchorage Screw

BOMEI CO., LTD. · Model BD-2024-0 · UDI-DI 04719873180240

OAT Prescription

510(k) clearances

337

Adverse events

Recalls

Facilities

Description

OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and pre-prosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length. • Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) • Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) There are three types of OBS Anchorage Screw. • Square collar mushroom head none hole • Square collar mushroom head round hole • Square collar mushroom head slot hole OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The sterilization recommendations documented in the instructions for use (IFU) are according to “AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities” have been validated. Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes. The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.

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.