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STRAUMANN ORTHOSYSTEM

Institut Straumann AG · Model Palatal-System · UDI-DI 07630031722706

OAT Prescription
1
510(k) clearances
337
Adverse events
3
Recalls
55
Facilities

Description

Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel

Recalls

DateFirmReason
2013-07-12Ormco/SybronendoOrmco 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
2007-09-28Straumann USA LLCSticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
2007-09-28Straumann USA LLCSticking 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.