Legacy™ Straight Abutment 8057-23

GUDID 10841307111788

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307111788
• NIH Device Record Key: 3f9567a0-2a62-4088-95a6-39f1c6140210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™ Straight Abutment
• Version Model Number: 8057-23
• Catalog Number: 8057-23
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10841307111788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061319

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

[10841307111788]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-14

On-Brand Devices [Legacy™ Straight Abutment]

• 10841307111818: 8530-23
• 10841307111801: 8530-22
• 10841307111795: 8530-21
• 10841307111788: 8057-23
• 10841307111771: 8057-22
• 10841307111764: 8057-21
• 10841307111757: 8045-23
• 10841307111740: 8045-22
• 10841307111733: 8045-21
• 10841307111726: 8035-23
• 10841307111719: 8035-22
• 10841307111702: 8035-21