International safety notice

It was discovered that a product that may not meet the bending strength standard value (240MPa or more) was being shipped. Therefore, we have decided to carry out a recall.

Japan / PMDA Recalls · JPN · Mar 15, 2024

Key facts

Title It was discovered that a product that may not meet the bending strength standard value (240MPa or more) was being shipped. Therefore, we have decided to carry out a recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Resin material for dental cutting Sales name: Artesano Durr
Manufacturer Yamahachi Dental Industry Co., Ltd.
Models D,SD58D,SD59D,SD60D,SD61D,SD62D,SD63D,SD64D,SD65D,SD66D,SD67D,SD68D,SD69D,SD70D,SD71D, D,QE09D,QE10D,QE11D,QE12D,QE13D,QE14D,QE15D,QE16D,QE17D,QE18D,QE19D,QE20D,QE21D,QE22D, D,QC27D,QC28D,QC29D,QC30D,QC31D,QC32D,QC33D,QC34D,QC35D,QC36D,QD01D,QD02D,QD03D,QD04D, 41D,RJ42D,RJ43D,RJ44D,RJ45D,RJ46D,RJ47D,RJ48D,RJ49D,RJ50D,RJ51D,RJ52D,RJ53D,RJ54D,RJ55, 58D,SH59D,SH60D,SH61D,SH62D,SH63D,SH64D,SH65D,SH66D,SH67D,SH68D,SH69D,SI01D,SI02D,SI03, ,SG34D,SG35D,SG36D,SG37D,SG38D,SG39D,SG40D,SG45D,SG46D,SG47D,SG48D,SG49D,SG50D,SG51D,, ,RG39D,RG40D,RG41D,RG42D,RG43D,RG44D,RG45D,RG46D,RG47D,RG48D,RG49D,RG50D,RG51D,RG52D,, 34D,PE35D,PE36D,PE37D,PE38D,PE39D,PE40D,PE41D,PE42D,PE43D,PE44D,PE45D,PE46D,PE47D,PF01, OL53D,OL54D,PA08D,PA09D,PA10D,PD04D,PD05D,PD06D,PD07D,PD08D,PD09D,PD12D,PD13D,PD14D,PD, 33D,QD34D,QD35D,QD36D,QD37D,QD38D,QD39D,QE01D,QE02D,QE03D,QE04D,QE05D,QE06D,QE07D,QE08, D,SG83D,SG84D,SG85D,SG86D,SG87D,SG88D,SG89D,SG90D,SH10D,SH11D,SH12D,SH13D,SH14D,SH15D, ,QG05D,QG06D,QG07D,QG08D,QG09D,QG10D,QG11D,QG12D,QG13D,QG14D,QG15D,QG16D,QG17D,QG18D, and 111 more
Date Mar 15, 2024
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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About International device safety notices

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Source: National medical device regulators (as listed), compiled by Orca1

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