RePlant® Straight Abutment 6035-21

GUDID 10841307113621

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307113621
• NIH Device Record Key: c9b6ddad-934c-48da-be53-593bfb2a37f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RePlant® Straight Abutment
• Version Model Number: 6035-21
• Catalog Number: 6035-21
• 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	10841307113621 [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

[10841307113621]

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 Abutment]

• 10841307113737: 6060-23
• 10841307113720: 6060-22
• 10841307113713: 6060-21
• 10841307113706: 6050-23
• 10841307113690: 6050-22
• 10841307113683: 6050-21
• 10841307113676: 6043-23
• 10841307113669: 6043-22
• 10841307113652: 6043-21
• 10841307113645: 6035-23
• 10841307113638: 6035-22
• 10841307113621: 6035-21