SPI ELEMENT

GUDID 07640156471328

Thommen Medical AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07640156471328
• NIH Device Record Key: 4bd95211-b242-4884-aeb9-e00dc4124832
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI ELEMENT
• Version Model Number: 4.13.952
• Company DUNS: 481614829
• Company Name: Thommen Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640156471328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072649

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [SPI ELEMENT]

• 07640156478778: 4.13.949
• 07640156478709: 4.13.939
• 07640156478693: 4.13.929
• 07640156478686: 4.13.919
• 07640156478679: 4.13.909
• 07640156471533: 4.13.900
• 07640156471526: 4.13.901
• 07640156471519: 4.13.902
• 07640156471502: 4.13.904
• 07640156471496: 4.13.910
• 07640156471489: 4.13.911
• 07640156471472: 4.13.912
• 07640156471465: 4.13.914
• 07640156471458: 4.13.920
• 07640156471441: 4.13.921
• 07640156471434: 4.13.922
• 07640156471427: 4.13.924
• 07640156471410: 4.13.930
• 07640156471403: 4.13.931
• 07640156471397: 4.13.934
• 07640156471380: 4.13.940
• 07640156471373: 4.13.941
• 07640156471366: 4.13.942
• 07640156471359: 4.13.944
• 07640156471342: 4.13.950
• 07640156471335: 4.13.951
• 07640156471328: 4.13.952
• 07640156470857: 4.13.905
• 07640156470840: 4.13.906
• 07640156470833: 4.13.907
• 07640156470826: 4.13.903
• 07640156470819: 4.13.908
• 07640156470802: 4.13.913
• 07640156470796: 4.13.943
• 07640156470789: 4.13.953