Implantium, Superline CAB5515

GUDID 08809740717467

Endosseous Dental Implant Abutment

Dentium Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809740717467
• NIH Device Record Key: 95c53efe-4c70-43b4-98e6-471eba95d00d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implantium, Superline
• Version Model Number: CAB5515
• Catalog Number: CAB5515
• 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

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809740717467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172640

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

[08809740717467]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-21

On-Brand Devices [Implantium, Superline]

• 08809544906661: Endosseous dental implant abutment
• 08809544906654: Endosseous dental implant abutment
• 08809544906647: Endosseous dental implant abutment
• 08809544906630: Endosseous dental implant abutment
• 08809544906623: Endosseous dental implant abutment
• 08809544906616: Endosseous dental implant abutment
• 08809544906609: Endosseous dental implant abutment
• 08809544906593: Endosseous dental implant abutment
• 08809544906586: Endosseous dental implant abutment
• 08809544906579: Endosseous dental implant abutment
• 08809544906562: Endosseous dental implant abutment
• 08809544906555: Endosseous dental implant abutment
• 08809544906548: Endosseous dental implant abutment
• 08809544906531: Endosseous dental implant abutment
• 08809544906524: Endosseous dental implant abutment
• 08809544906517: Endosseous dental implant abutment
• 08809544906500: Endosseous dental implant abutment
• 08809544906494: Endosseous dental implant abutment
• 08809544906487: Endosseous dental implant abutment
• 08809544906470: Endosseous dental implant abutment
• 08809544906463: Endosseous dental implant abutment
• 08809544906456: Endosseous dental implant abutment
• 08809544906449: Endosseous dental implant abutment
• 08809544906432: Endosseous dental implant abutment
• 08809460300536: Endosseous dental implant
• 08809460300529: Endosseous dental implant
• 08809162706667: Endosseous dental implant abutment
• 08809162702256: Endosseous Dental Implant Abutment
• 08809162702249: Endosseous Dental Implant Abutment
• 08809162702164: Endosseous dental implant abutment
• 08809162702157: Endosseous dental implant abutment
• 08809162702140: Endosseous dental implant abutment
• 08809162702096: Endosseous dental implant abutment
• 08809162702089: Endosseous dental implant abutment
• 08809162702072: Endosseous dental implant abutment
• 08809162702003: Endosseous dental implant abutment
• 08809162701983: Endosseous dental implant abutment
• 08809162701167: Endosseous Dental Implant Abutment
• 08809162701150: Endosseous Dental Implant Abutment
• 08809162701082: Endosseous dental implant abutment
• 08809162701075: Endosseous dental implant abutment
• 08809162701068: Endosseous dental implant abutment
• 08809162701051: Endosseous dental implant abutment
• 08809162701020: Endosseous dental implant abutment
• 08809162701013: Endosseous dental implant abutment
• 08809162701006: Endosseous dental implant abutment
• 08809162700993: Endosseous dental implant abutment
• 08809162700986: Endosseous dental implant abutment
• 08809162700979: Endosseous dental implant abutment
• 08809162700962: Endosseous dental implant abutment