SPI RETAIN

GUDID 07640156473735

Thommen Medical AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07640156473735
• NIH Device Record Key: 93e61f63-a232-40f6-b06f-fd81ea444f37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI RETAIN
• Version Model Number: 4.03.422
• 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	07640156473735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031747

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07640156473735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-24

On-Brand Devices [SPI RETAIN]

• 07640156473964: 4.03.040
• 07640156473957: 4.03.041
• 07640156473940: 4.03.042
• 07640156473933: 4.03.043
• 07640156473926: 4.03.048
• 07640156473919: 4.03.049
• 07640156473902: 4.03.070
• 07640156473797: 4.03.380
• 07640156473780: 4.03.381
• 07640156473773: 4.03.382
• 07640156473766: 4.03.388
• 07640156473759: 4.03.420
• 07640156473742: 4.03.421
• 07640156473735: 4.03.422
• 07640156473728: 4.03.423
• 07640156473711: 4.03.428
• 07640156473704: 4.03.500
• 07640156473698: 4.03.502
• 07640156473681: 4.03.506
• 07640156473674: 4.03.507
• 07640156471830: 4.03.501