Legacy™ Multi-Unit Abutment 8530-65

GUDID 10841307126775

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307126775
• NIH Device Record Key: 76f1f3aa-807e-4880-949a-bfa0c6b878fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™ Multi-Unit Abutment
• Version Model Number: 8530-65
• Catalog Number: 8530-65
• 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: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10841307126775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

[10841307126775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Legacy™ Multi-Unit Abutment]

• 10841307126775: 8530-65
• 10841307126768: 8530-64
• 10841307126751: 8530-63
• 10841307126744: 8530-62
• 10841307126737: 8530-61
• 10841307126720: 8057-64
• 10841307126713: 8057-62
• 10841307126706: 8057-61
• 10841307126690: 8045-64
• 10841307126683: 8045-62
• 10841307126676: 8045-61
• 10841307126669: 8035-64
• 10841307126652: 8035-62
• 10841307126645: 8035-61