SimpleLine II SOCAB6518O

GUDID 08809162702508

Endosseous dental implant abutment

Dentium Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809162702508
• NIH Device Record Key: e08b2f2c-0e35-414e-b22f-d77638af1827
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimpleLine II
• Version Model Number: SOCAB6518O
• Catalog Number: SOCAB6518O
• 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: 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(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Length: 9.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809162702508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112045

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[08809162702508]

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: 2016-10-12

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