ScrewIndirect® Implant 403716

GUDID 10841307104797

Ø3.7 x 8 Platform 3.5mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307104797
• NIH Device Record Key: ae483ef7-fde3-4aa0-a8aa-354230d2ca14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScrewIndirect® Implant
• Version Model Number: 403716
• Catalog Number: 403716
• 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	10841307104797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061319

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 [ScrewIndirect® Implant]

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• 10841307104865: Ø3.7 x 8 Platform 3.5mmD
• 10841307104858: Ø3.7 x 8 Platform 3.5mmD
• 10841307104841: Ø3.7 x 8 Platform 3.5mmD
• 10841307104834: Ø3.7 x 8 Platform 3.5mmD
• 10841307104810: Ø3.7 x 8 Platform 3.5mmD
• 10841307104803: Ø3.7 x 8 Platform 3.5mmD
• 10841307104797: Ø3.7 x 8 Platform 3.5mmD
• 10841307104780: Ø3.7 x 8 Platform 3.5mmD
• 10841307104766: Ø3.7 x 8 Platform 3.5mmD
• 10841307104759: Ø3.7 x 8 Platform 3.5mmD
• 10841307104742: Ø3.7 x 8 Platform 3.5mmD
• 10841307104735: Ø3.7 x 8 Platform 3.5mmD
• 10841307104711: Ø3.7 x 8 Platform 3.5mmD
• 10841307104704: Ø3.7 x 8 Platform 3.5mmD