INNO SLA Submerged Implant System-Abutment Screw

GUDID 08800016119824

Cowellmedi Co.,Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800016119824
• NIH Device Record Key: 9f731afc-0ef1-49d1-a1b9-fb061f3567c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO SLA Submerged Implant System-Abutment Screw
• Version Model Number: 2SBS300
• Company DUNS: 688753763
• Company Name: Cowellmedi Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800016119824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201323

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

[08800016119824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-03
• Device Publish Date: 2024-05-24

On-Brand Devices [INNO SLA Submerged Implant System-Abutment Screw]

• 08800016119831: 2SBS200
• 08800016119824: 2SBS300
• 08800016119817: 2SBS400
• 08800016103816: 2SSHR400
• 08800016103168: 2SSHR300