SimpleLine II SOHAB4810

GUDID 08809691365243

Abutment, Implant, Dental, Endosseous

Dentium Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809691365243
• NIH Device Record Key: 6bc28585-18e2-4666-ad3a-5631031cd6bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimpleLine II
• Version Model Number: SOHAB4810
• Catalog Number: SOHAB4810
• 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

• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809691365243 [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

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