simplyFixed RePlant® Angled 6043-64-15K

GUDID 10841307118954

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307118954
• NIH Device Record Key: ee7ba2f3-2860-43c3-bd53-cdd3f050a0b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simplyFixed RePlant® Angled
• Version Model Number: 6043-64-15K
• Catalog Number: 6043-64-15K
• 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	10841307118954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081101

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307118954]

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: 2015-10-16

On-Brand Devices [simplyFixed RePlant® Angled]

• 10841307118985: 6050-64-30K
• 10841307118978: 6050-64-15K
• 10841307118961: 6043-64-30K
• 10841307118954: 6043-64-15K
• 10841307118947: 6035-64-30K
• 10841307118930: 6035-64-15K