Implantium, Superline XPK

GUDID 08809460301502

Accessories, Implant, Dental, Endosseous

Dentium Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08809460301502
• NIH Device Record Key: c344cbf9-f682-449c-a1a6-f671b7dee927
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implantium, Superline
• Version Model Number: XPK
• Catalog Number: XPK
• Company DUNS: 689514395
• Company Name: Dentium Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809460301502 [Primary]

FDA Product Code

• ECT: DRIVER, BAND, ORTHODONTIC
• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08809460301502]

Moist Heat or Steam Sterilization

[08809460301502]

Moist Heat or Steam Sterilization

[08809460301502]

Moist Heat or Steam Sterilization

[08809460301502]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-14

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