Legacy™2 Implant 827011

GUDID 10841307101567

7.0mmD x 11.5mmL, 5.7mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307101567
• NIH Device Record Key: afb2db9d-b96f-44e9-b085-b63c6ed2ca3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™2 Implant
• Version Model Number: 827011
• Catalog Number: 827011
• 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
• 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 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	10841307101567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192221

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: 2020-08-07
• Device Publish Date: 2015-09-14

On-Brand Devices [Legacy™2 Implant]

• 10841307101970: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307101963: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307101956: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307101949: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307101925: 5.7mmD x 16mmL, 5.7mmD Platform
• 10841307101918: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307101901: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307101895: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307101888: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307101864: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307101857: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307101840: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307101833: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307101826: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307101802: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307101796: 4.7mmD x 13mmL, 4.5mmD Platform
• 10841307101789: 4.7mmD x 11.5mmL, 4.5mmD Platform
• 10841307101772: 4.7mmD x 10mmL, 4.5mmD Platform
• 10841307101765: 4.7mmD x 8mmL, 4.5mmD Platform
• 10841307101741: 4.2mmD x 16mmL, 3.5mmD Platform
• 10841307101734: 4.2mmD x 13mmL, 3.5mmD Platform
• 10841307101727: 4.2mmD x 11.5mmL, 3.5mmD Platform
• 10841307101710: 4.2mmD x 10mmL, 3.5mmD Platform
• 10841307101703: 4.2mmD x 8mmL, 3.5mmD Platform
• 10841307101680: 3.7mmD x 16mmL, 3.5mmD Platform
• 10841307101673: 3.7mmD x 13mmL, 3.5mmD Platform
• 10841307101666: 3.7mmD x 11.5mmL, 3.5mmD Platform
• 10841307101659: 3.7mmD x 10mmL, 3.5mmD Platform
• 10841307101642: 3.7mmD x 8mmL, 3.5mmD Platform
• 10841307101628: 3.2mmD x 16mmL, 3.0mmD Platform
• 10841307101611: 3.2mmD x 13mmL, 3.0mmD Platform
• 10841307101604: 3.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307101598: 3.2mmD x 10mmL, 3.0mmD Platform
• 10841307101581: 3.2mmD x 8mmL, 3.0mmD Platform
• 10841307101574: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307101567: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307101550: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307101543: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307101529: 5.7mmD x 16mmL, 5.7mmD Platform
• 10841307101512: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307101505: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307101499: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307101482: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307101468: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307101451: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307101444: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307101437: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307101420: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307101406: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307101390: 4.7mmD x 13mmL, 4.5mmD Platform