RePlant® Straight Contoured Abutment 6050-31

GUDID 10841307113843

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307113843
• NIH Device Record Key: a408ff10-7267-432c-903a-c29071c3ac09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RePlant® Straight Contoured Abutment
• Version Model Number: 6050-31
• Catalog Number: 6050-31
• 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	10841307113843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081396

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307113843]

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 [RePlant® Straight Contoured Abutment]

• 10841307113935: 6060-32-90
• 10841307113928: 6060-32-60
• 10841307113911: 6060-32-30
• 10841307113904: 6060-32
• 10841307113898: 6060-31
• 10841307113881: 6050-32-90
• 10841307113874: 6050-32-60
• 10841307113867: 6050-32-30
• 10841307113850: 6050-32
• 10841307113843: 6050-31
• 10841307113836: 6043-32-90
• 10841307113829: 6043-32-60
• 10841307113812: 6043-32-30
• 10841307113805: 6043-32
• 10841307113799: 6043-31
• 10841307113782: 6035-32-90
• 10841307113775: 6035-32-60
• 10841307113768: 6035-32-30
• 10841307113751: 6035-32
• 10841307113744: 6035-31