INNO SLA Submerged Implant System-Temporary Abutment

GUDID 08800016101027

Cowellmedi Co.,Ltd

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800016101027
• NIH Device Record Key: ffabdfa4-7405-4d57-94ba-0c6538c4a3be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO SLA Submerged Implant System-Temporary Abutment
• Version Model Number: 2STHA45
• 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	08800016101027 [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

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

Moist Heat or Steam Sterilization

[08800016101027]

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-Temporary Abutment]

• 08809471723140: 2STHA002
• 08809471723201: 2STNA004
• 08809471723195: 2STNA003
• 08809471723188: 2STNA002
• 08809471723164: 2STHA004
• 08809471723157: 2STHA003
• 08800016101027: 2STHA45
• 08800016101010: 2STNA45