SDS1.2

GUDID 04260468251246

Dental Implant

SDS Swiss Dental Solutions AG

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system 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

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