simply Legacy™2 Implant 824216U

GUDID 10841307107439

4.2mmD x 16mmL, 3.5mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307107439
• NIH Device Record Key: 6b358033-4771-4507-b3cb-0327aaa56bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simply Legacy™2 Implant
• Version Model Number: 824216U
• Catalog Number: 824216U
• 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
• 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 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	10841307107439 [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: 2020-08-10
• Device Publish Date: 2015-09-14

On-Brand Devices [simply Legacy™2 Implant]

• 10841307107620: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307107613: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307107606: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307107590: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307107583: 5.7mmD x 16mmL, 5.7mmD Platform
• 10841307107576: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307107569: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307107552: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307107545: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307107538: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307107521: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307107514: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307107507: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307107491: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307107484: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307107477: 4.7mmD x 13mmL, 4.5mmD Platform
• 10841307107460: 4.7mmD x 11.5mmL, 4.5mmD Platform
• 10841307107453: 4.7mmD x 10mmL, 4.5mmD Platform
• 10841307107446: 4.7mmD x 8mmL, 4.5mmD Platform
• 10841307107439: 4.2mmD x 16mmL, 3.5mmD Platform
• 10841307107422: 4.2mmD x 13mmL, 3.5mmD Platform
• 10841307107415: 4.2mmD x 11.5mmL, 3.5mmD Platform
• 10841307107408: 4.2mmD x 10mmL, 3.5mmD Platform
• 10841307107392: 4.2mmD x 8mmL, 3.5mmD Platform
• 10841307107385: 3.7mmD x 16mmL, 3.5mmD Platform
• 10841307107378: 3.7mmD x 13mmL, 3.5mmD Platform
• 10841307107361: 3.7mmD x 11.5mmL, 3.5mmD Platform
• 10841307107354: 3.7mmD x 10mmL, 3.5mmD Platform
• 10841307107347: 3.7mmD x 8mmL, 3.5mmD Platform
• 10841307107330: 3.2mmD x 16mmL, 3.0mmD Platform
• 10841307107323: 3.2mmD x 13mmL, 3.0mmD Platform
• 10841307107316: 3.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307107309: 3.2mmD x 10mmL, 3.0mmD Platform
• 10841307107293: 3.2mmD x 8mmL, 3.0mmD Platform
• 10841307107286: 7.0mmD x 6mmL, 5.7mmD Platform
• 10841307107279: 5.7mmD x 6mmL, 5.7mmD Platform
• 10841307107262: 5.2mmD x 6mmL, 4.5mmD Platform
• 10841307107255: 4.7mmD x 6mmL, 4.5mmD Platform
• 10841307107248: 4.2mmD x 6mmL, 3.5mmD Platform
• 10841307107231: 3.7mmD x 6mmL, 3.5mmD Platform