SDS1.2

GUDID 04260468251246

Dental Implant

SDS Swiss Dental Solutions AG

Dental implant system

• Primary Device ID: 04260468251246
• NIH Device Record Key: 5ac66e04-2245-449e-9e7e-ce94a8881372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDS1.2
• Version Model Number: SDS1.2_4611
• Company DUNS: 487103033
• Company Name: SDS Swiss Dental Solutions AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com
• Phone: (774) 634-6225
• Email: info.us@swissdentalsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260468251246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181953

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-13
• Device Publish Date: 2020-08-05

On-Brand Devices [SDS1.2]

• 04260468255374: SDS1.2 healing cap-disc 9x12
• 04260468255367: SDS1.2 healing cap-disc 9x9
• 04260468254285: SDS1.2 3.3 mm temporary cap
• 04260468254247: Insertion tool SDS1.2, short
• 04260468254230: Insertion tool SDS1.2
• 04260468254223: SDS1.2 standard titanium screw
• 04260468251895: Dental Implant
• 04260468251413: Dental Implant
• 04260468251406: Dental Implant
• 04260468251390: Dental Implant
• 04260468251383: Dental Implant
• 04260468251277: Dental Implant
• 04260468251260: Dental Implant
• 04260468251253: Dental Implant
• 04260468251246: Dental Implant
• 04260468251239: Dental Implant
• 04260468251222: Dental Implant
• 04260468251215: Dental Implant
• 04260468251208: Dental Implant
• 04260468251192: Dental Implant
• 04260468250645: Dental Implant
• 04260468250508: Dental Implant
• 04260468250171: SDS1.2 4.6 mm temporary cap
• 04260468250164: SDS1.2 3.8 mm temporary cap