SwishActive™ Implant 944814

GUDID 10841307106746

Ø3.7 x 8 Platform 3.5mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307106746
• NIH Device Record Key: 233b4cdc-897d-42eb-9251-09ae2fe8d219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwishActive™ Implant
• Version Model Number: 944814
• Catalog Number: 944814
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• 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: true
• 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: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307106746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130572

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: 4
• Public Version Date: 2024-12-20
• Device Publish Date: 2015-09-14

On-Brand Devices [SwishActive™ Implant]

• 10841307106746: Ø3.7 x 8 Platform 3.5mmD
• 10841307106739: Ø3.7 x 8 Platform 3.5mmD
• 10841307106722: Ø3.7 x 8 Platform 3.5mmD
• 10841307106715: Ø3.7 x 8 Platform 3.5mmD
• 10841307106708: Ø3.7 x 8 Platform 3.5mmD
• 10841307106692: Ø3.7 x 8 Platform 3.5mmD
• 10841307106685: Ø3.7 x 8 Platform 3.5mmD
• 10841307106678: Ø3.7 x 8 Platform 3.5mmD
• 10841307106661: Ø3.7 x 8 Platform 3.5mmD
• 10841307106654: Ø3.7 x 8 Platform 3.5mmD
• 10841307106647: Ø3.7 x 8 Platform 3.5mmD
• 10841307106630: Ø3.7 x 8 Platform 3.5mmD
• 10841307106623: Ø3.7 x 8 Platform 3.5mmD
• 10841307106616: Ø3.7 x 8 Platform 3.5mmD
• 10841307106609: Ø3.7 x 8 Platform 3.5mmD
• 10841307106593: Ø3.7 x 8 Platform 3.5mmD