FDA-Device2017-10-11Class II
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Implant Direct Sybron Manufacturing, LLC
Hazard
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Sold states
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Affected count
50 units
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2018Don't want to check this manually?
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