Angled Abutment 1057-52

GUDID 10841307114369

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307114369
• NIH Device Record Key: f3dbdb0a-e89b-4e6d-97e0-aa4a64f8d0e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angled Abutment
• Version Model Number: 1057-52
• Catalog Number: 1057-52
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307114369 [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

[10841307114369]

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 [Angled Abutment]

• 10841307114369: 1057-52
• 10841307114352: 1057-51
• 10841307114345: 1047-52
• 10841307114338: 1047-51
• 10841307114321: 1037-52
• 10841307114314: 1037-51