simply InterActive® Implant 654311U

GUDID 10841307106944

Ø3.7 x 8 Platform 3.5mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307106944
• NIH Device Record Key: 0042e254-52e9-41f2-92df-efdee1e4f504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simply InterActive® Implant
• Version Model Number: 654311U
• Catalog Number: 654311U
• 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	10841307106944 [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

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• 10841307106999: Ø3.7 x 8 Platform 3.5mmD
• 10841307106982: Ø3.7 x 8 Platform 3.5mmD
• 10841307106975: Ø3.7 x 8 Platform 3.5mmD
• 10841307106968: Ø3.7 x 8 Platform 3.5mmD
• 10841307106951: Ø3.7 x 8 Platform 3.5mmD
• 10841307106944: Ø3.7 x 8 Platform 3.5mmD
• 10841307106937: Ø3.7 x 8 Platform 3.5mmD
• 10841307106920: Ø3.7 x 8 Platform 3.5mmD
• 10841307106913: Ø3.7 x 8 Platform 3.5mmD
• 10841307106906: Ø3.7 x 8 Platform 3.5mmD
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• 10841307106852: Ø3.7 x 8 Platform 3.5mmD
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• 10841307106838: Ø3.7 x 8 Platform 3.5mmD
• 10841307106821: Ø3.7 x 8 Platform 3.5mmD
• 10841307106814: Ø3.7 x 8 Platform 3.5mmD
• 10841307106807: Ø3.7 x 8 Platform 3.5mmD