SPI ART

GUDID 07640156476545

Thommen Medical AG

Dental implant suprastructure kit

• Primary Device ID: 07640156476545
• NIH Device Record Key: bb529e46-fb1e-48e8-8775-cb2c53982d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI ART
• Version Model Number: 1.03.625
• 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: false
• 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	07640156476545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061807

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

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 ART ]

• 07640156476569: 1.03.623
• 07640156476552: 1.03.624
• 07640156476545: 1.03.625
• 07640156476538: 1.03.626
• 07640156476521: 1.03.649
• 07640156476514: 1.03.650
• 07640156476507: 1.03.651
• 07640156476491: 1.03.652