Legacy™4 Implant 885710

GUDID 10841307103493

5.7mmD x 10mmL, 5.7mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system

• Primary Device ID: 10841307103493
• NIH Device Record Key: 804d8459-343f-44df-97cf-efd03dc872bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™4 Implant
• Version Model Number: 885710
• Catalog Number: 885710
• 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	10841307103493 [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™4 Implant]

• 10841307103578: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307103561: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307103554: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307103547: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307103516: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307103509: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307103493: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307103486: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307103462: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307103455: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307103448: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307103431: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307103424: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307103400: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307103394: 4.7mmD x 13mmL, 4.5mmD Platform
• 10841307103387: 4.7mmD x 11.5mmL, 4.5mmD Platform
• 10841307103370: 4.7mmD x 10mmL, 4.5mmD Platform
• 10841307103363: 4.7mmD x 8mmL, 4.5mmD Platform
• 10841307103349: 4.2mmD x 16mmL, 3.5mmD Platform
• 10841307103332: 4.2mmD x 13mmL, 3.5mmD Platform
• 10841307103325: 4.2mmD x 11.5mmL, 3.5mmD Platform
• 10841307103318: 4.2mmD x 10mmL, 3.5mmD Platform
• 10841307103301: 4.2mmD x 8mmL, 3.5mmD Platform
• 10841307103288: 3.7mmD x 16mmL, 3.5mmD Platform
• 10841307103271: 3.7mmD x 13mmL, 3.5mmD Platform
• 10841307103264: 3.7mmD x 11.5mmL, 3.5mmD Platform
• 10841307103257: 3.7mmD x 10mmL, 3.5mmD Platform
• 10841307103240: 3.7mmD x 8mmL, 3.5mmD Platform
• 10841307103226: 3.2mmD x 16mmL, 3.0mmD Platform
• 10841307103219: 3.2mmD x 13mmL, 3.0mmD Platform
• 10841307103202: 3.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307103196: 3.2mmD x 10mmL, 3.0mmD Platform
• 10841307103189: 3.2mmD x 8mmL, 3.0mmD Platform
• 10841307103172: 7.0mmD x 13mmL, 5.7mmD Platform
• 10841307103165: 7.0mmD x 11.5mmL, 5.7mmD Platform
• 10841307103158: 7.0mmD x 10mmL, 5.7mmD Platform
• 10841307103141: 7.0mmD x 8mmL, 5.7mmD Platform
• 10841307103127: 5.7mmD x 16mmL, 5.7mmD Platform
• 10841307103110: 5.7mmD x 13mmL, 5.7mmD Platform
• 10841307103103: 5.7mmD x 11.5mmL, 5.7mmD Platform
• 10841307103097: 5.7mmD x 10mmL, 5.7mmD Platform
• 10841307103080: 5.7mmD x 8mmL, 5.7mmD Platform
• 10841307103066: 5.2mmD x 16mmL, 4.5mmD Platform
• 10841307103059: 5.2mmD x 13mmL, 4.5mmD Platform
• 10841307103042: 5.2mmD x 11.5mmL, 4.5mmD Platform
• 10841307103035: 5.2mmD x 10mmL, 4.5mmD Platform
• 10841307103028: 5.2mmD x 8mmL, 4.5mmD Platform
• 10841307103004: 4.7mmD x 16mmL, 4.5mmD Platform
• 10841307102991: 4.7mmD x 13mmL, 4.5mmD Platform
• 10841307102984: 4.7mmD x 11.5mmL, 4.5mmD Platform