SimpleLine II SOSAB4816

GUDID 08809460302141

Endosseous dental implant abutment

Dentium Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809460302141
• NIH Device Record Key: d4bc7083-0534-4aef-a6e1-0dc02f7a7695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimpleLine II
• Version Model Number: SOSAB4816
• Catalog Number: SOSAB4816
• 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
• 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
• 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
• 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
• 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
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809460302141 [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

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

[08809460302141]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-02
• Device Publish Date: 2021-01-25

On-Brand Devices [SimpleLine II]

• 08809544906425: Endosseous dental implant
• 08809544906418: Endosseous dental implant
• 08809544906401: Endosseous dental implant
• 08809162700719: Endosseous dental implant
• 08809460302097: Endosseous dental implant abutment
• 08809460302080: Endosseous dental implant abutment
• 08809460302073: Endosseous dental implant abutment
• 08809460302066: Endosseous dental implant abutment
• 08809460302059: Endosseous dental implant abutment
• 08809460302042: Endosseous dental implant abutment
• 08809460302035: Endosseous dental implant abutment
• 08809460302028: Endosseous dental implant abutment
• 08809460302011: Endosseous dental implant abutment
• 08809460302004: Endosseous dental implant abutment
• 08809460301991: Endosseous dental implant abutment
• 08809460301984: Endosseous dental implant abutment
• 08809460301977: Endosseous dental implant abutment
• 08809460301960: Endosseous dental implant abutment
• 08809460301953: Endosseous dental implant abutment
• 08809162705899: Endosseous dental implant abutment screw
• 08809162702744: Endosseous dental implant abutment
• 08809162702737: Endosseous dental implant abutment
• 08809162702720: Endosseous dental implant abutment
• 08809162702713: Endosseous dental implant abutment
• 08809162702706: Endosseous dental implant abutment
• 08809162702690: Endosseous dental implant abutment
• 08809162702669: Endosseous dental implant abutment
• 08809162702652: Endosseous dental implant abutment
• 08809162702645: Endosseous dental implant abutment
• 08809162702638: Endosseous dental implant abutment
• 08809162702621: Endosseous dental implant abutment
• 08809162702607: Endosseous dental implant abutment
• 08809162702584: Endosseous dental implant abutment
• 08809162702560: Endosseous dental implant abutment
• 08809162702546: Endosseous dental implant abutment
• 08809162702522: Endosseous dental implant abutment
• 08809162702508: Endosseous dental implant abutment
• 08809162702492: Endosseous dental implant abutment
• 08809162702485: Endosseous dental implant abutment
• 08809162702478: Endosseous dental implant abutment
• 08809162702461: Endosseous dental implant abutment
• 08809162702454: Endosseous dental implant abutment
• 08809162702447: Endosseous dental implant abutment
• 08809162702430: Endosseous dental implant abutment
• 08809162702409: Endosseous dental implant abutment
• 08809162702393: Endosseous dental implant abutment
• 08809162702386: Endosseous dental implant abutment
• 08809162702379: Endosseous dental implant abutment
• 08809691365274: Abutment, Implant, Dental, Endosseous
• 08809691365267: Abutment, Implant, Dental, Endosseous