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Devices
Device Recall SwishPlus Implant
Model / Serial
Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Product Description
SwishPlus Implant || Intended for use in support for fixed bridgework.
Manufacturer
Implant Direct Sybron Manufacturing, LLC
1 Event
Recall of Device Recall SwishPlus Implant
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Manufacturer
Implant Direct Sybron Manufacturing, LLC
Manufacturer Address
Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA
Language
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