Legacy™3 Implant 867013

GUDID 10841307102779

7.0mmD x 13mmL, 5.7mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307102779
• NIH Device Record Key: 732dae28-60ed-4e4f-b3ca-3c7a642e7c72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™3 Implant
• Version Model Number: 867013
• Catalog Number: 867013
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10841307102779 [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 [Legacy™3 Implant]

• 10841307102359: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307102342: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307102779: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307102762: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307102755: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307102748: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307102373: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307102366: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307102335: Ø7.0 x 6 Platform 5.7mmD
• 10841307102328: Ø5.7 x 16 Platform 5.7mmD
• 10841307102311: Ø5.7 x 13 Platform 5.7mmD
• 10841307102304: Ø5.7 x 11.5 Platform 5.7mmD
• 10841307102298: Ø5.7 x 10 Platform 5.7mmD
• 10841307102281: Ø5.7 x 8 Platform 5.7mmD
• 10841307102274: Ø5.7 x 6 Platform 5.7mmD
• 10841307102267: Ø5.2 x 16 Platform 4.5mmD
• 10841307102250: Ø5.2 x 13 Platform 4.5mmD
• 10841307102243: Ø5.2 x 11.5 Platform 4.5mmD
• 10841307102236: Ø5.2 x 10 Platform 4.5mmD
• 10841307102229: Ø5.2 x 8 Platform 4.5mmD
• 10841307102212: Ø5.2 x 6 Platform 4.5mmD
• 10841307102205: Ø4.7 x 16 Platform 4.5mmD
• 10841307102199: Ø4.7 x 13 Platform 4.5mmD
• 10841307102182: Ø4.7 x 11.5 Platform 4.5mmD
• 10841307102175: Ø4.7 x 10 Platform 4.5mmD
• 10841307102168: Ø4.7 x 8 Platform 4.5mmD
• 10841307102151: Ø4.7 x 6 Platform 4.5mmD
• 10841307102144: Ø4.2 x 16 Platform 3.5mmD
• 10841307102137: Ø4.2 x 13 Platform 3.5mmD
• 10841307102120: Ø4.2 x 11.5 Platform 3.5mmD
• 10841307102113: Ø4.2 x 10 Platform 3.5mmD
• 10841307102106: Ø4.2 x 8 Platform 3.5mmD
• 10841307102090: Ø4.2 x 6 Platform 3.5mmD
• 10841307102083: Ø3.7 x 16 Platform 3.5mmD
• 10841307102076: Ø3.7 x 13 Platform 3.5mmD
• 10841307102069: Ø3.7 x 11.5 Platform 3.5mmD
• 10841307102052: Ø3.7 x 10 Platform 3.5mmD
• 10841307102045: Ø3.7 x 8 Platform 3.5mmD
• 10841307102038: Ø3.7 x 6 Platform 3.5mmD
• 10841307102021: Ø3.2 x 16 Platform 3.0mmD
• 10841307102014: Ø3.2 x 13 Platform 3.0mmD
• 10841307102007: Ø3.2 x 11.5 Platform 3.0mmD
• 10841307101994: Ø3.2 x 10 Platform 3.0mmD
• 10841307101987: Ø3.2 x 8 Platform 3.0mmD