FDA-Device2018-10-17Class II

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Implant Direct Sybron Manufacturing, LLC
Hazard

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

Sold states
Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Affected count
217 units
Manufactured in
3050 E Hillcrest Dr, Thousand Oaks, CA, United States
Products
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2019

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