NR Line GHAB653545

GUDID 08809691363522

Abutment, Implant, Dental, Endosseous

Dentium Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809691363522
• NIH Device Record Key: 825c8a58-3cec-4706-8473-33d68359707d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NR Line
• Version Model Number: GHAB653545
• Catalog Number: GHAB653545
• Company DUNS: 689514395
• Company Name: Dentium Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 10.1 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809691363522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192436

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-02
• Device Publish Date: 2020-05-25

On-Brand Devices [NR Line]

• 08809460306569: Endosseous dental implant abutment
• 08809460306552: Endosseous dental implant abutment
• 08809460306545: Endosseous dental implant abutment
• 08809460306538: Endosseous dental implant abutment
• 08809460306521: Endosseous dental implant abutment
• 08809460306514: Endosseous dental implant abutment
• 08809460306507: Endosseous dental implant abutment
• 08809460306491: Endosseous dental implant abutment
• 08809460306484: Endosseous dental implant abutment
• 08809460306477: Endosseous dental implant abutment
• 08809460306460: Endosseous dental implant abutment
• 08809460306453: Endosseous dental implant abutment
• 08809460306446: Endosseous dental implant abutment
• 08809460306439: Endosseous dental implant abutment
• 08809460306422: Endosseous dental implant abutment
• 08809460306415: Endosseous dental implant abutment
• 08809460306408: Endosseous dental implant abutment
• 08809460306392: Endosseous dental implant abutment
• 08809460306385: Endosseous dental implant abutment
• 08809460306378: Endosseous dental implant abutment
• 08809460306361: Endosseous dental implant abutment
• 08809460306354: Endosseous dental implant abutment
• 08809460306347: Endosseous dental implant abutment
• 08809460306330: Endosseous dental implant abutment
• 08809460306323: Endosseous dental implant abutment
• 08809460306316: Endosseous dental implant abutment
• 08809460306309: Endosseous dental implant abutment
• 08809460306293: Endosseous dental implant abutment
• 08809460306286: Endosseous dental implant abutment
• 08809460306279: Endosseous dental implant abutment
• 08809460306262: Endosseous dental implant abutment
• 08809460306255: Endosseous dental implant abutment
• 08809460306248: Endosseous dental implant abutment
• 08809460306231: Endosseous dental implant abutment
• 08809460306224: Endosseous dental implant abutment
• 08809460306002: Endosseous dental implant abutment
• 08809460305999: Endosseous dental implant abutment
• 08809460305982: Endosseous dental implant abutment
• 08809460305975: Endosseous dental implant abutment
• 08809460305968: Endosseous dental implant abutment
• 08809460305951: Endosseous dental implant abutment
• 08809460305944: Endosseous dental implant abutment
• 08809460305937: Endosseous dental implant abutment
• 08809460305920: Endosseous dental implant abutment
• 08809460305913: Endosseous dental implant abutment
• 08809460305906: Endosseous dental implant abutment
• 08809460305890: Endosseous dental implant abutment
• 08809460305883: Endosseous dental implant abutment
• 08809460305876: Endosseous dental implant abutment
• 08809460305869: Endosseous dental implant abutment