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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: TSX Implants
Classification Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
Product Code: DZE
Device Class: 2
Regulation Number: 872.3640
Medical Specialty: Dental
Registered Establishment Name: ZimVie Canada Inc.
Registered Establishment Number: 1000244346
Premarket Submission Number: K220978
Owner/Operator: ZimVie US Corp LLC
Owner/Operator Number: 1038806
Establishment Operations: Foreign Exporter
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