simply Legacy™3 Implant 854206U

GUDID 10841307107644

Ø3.7 x 8 Platform 3.5mmD

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307107644
• NIH Device Record Key: d561e001-7c99-48fe-9ee8-3c974e24f5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simply Legacy™3 Implant
• Version Model Number: 854206U
• Catalog Number: 854206U
• 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	10841307107644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131097

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 [simply Legacy™3 Implant]

• 10841307108023: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307108016: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307108009: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307107996: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307107989: 5.7mmD x 16mmL, 5.7mmD Platform
• 10841307107972: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307107965: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307107958: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307107941: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307107934: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307107927: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307107910: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307107903: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307107897: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307107880: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307107873: 4.7mmD x 13mmL, 4.5mmD Platform
• 10841307107866: 4.7mmD x 11.5mmL, 4.5mmD Platform
• 10841307107859: 4.7mmD x 10mmL, 4.5mmD Platform
• 10841307107842: 4.7mmD x 8mmL, 4.5mmD Platform
• 10841307107835: 4.2mmD x 16mmL, 3.5mmD Platform
• 10841307107828: 4.2mmD x 13mmL, 3.5mmD Platform
• 10841307107811: 4.2mmD x 11.5mmL, 3.5mmD Platform
• 10841307107804: 4.2mmD x 10mmL, 3.5mmD Platform
• 10841307107798: 4.2mmD x 8mmL, 3.5mmD Platform
• 10841307107781: 3.7mmD x 16mmL, 3.5mmD Platform
• 10841307107774: 3.7mmD x 13mmL, 3.5mmD Platform
• 10841307107767: 3.7mmD x 11.5mmL, 3.5mmD Platform
• 10841307107750: 3.7mmD x 10mmL, 3.5mmD Platform
• 10841307107743: 3.7mmD x 8mmL, 3.5mmD Platform
• 10841307107736: 3.2mmD x 16mmL, 3.0mmD Platform
• 10841307107729: 3.2mmD x 13mmL, 3.0mmD Platform
• 10841307107712: 3.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307107705: 3.2mmD x 10mmL, 3.0mmD Platform
• 10841307107699: 3.2mmD x 8mmL, 3.0mmD Platform
• 10841307107682: 7.0mmD x 6mmL, 5.7mmD Platform
• 10841307107675: Ø3.7 x 8 Platform 3.5mmD
• 10841307107668: Ø3.7 x 8 Platform 3.5mmD
• 10841307107651: Ø3.7 x 8 Platform 3.5mmD
• 10841307107644: Ø3.7 x 8 Platform 3.5mmD
• 10841307107637: Ø3.7 x 8 Platform 3.5mmD