INNO Implant System-Ball Abutment

GUDID 08809471724666

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw

• Primary Device ID: 08809471724666
• NIH Device Record Key: ceaed8b3-0086-46b2-9161-42fae778e8a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Implant System-Ball Abutment
• Version Model Number: 2SBAT444
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809471724666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

[08809471724666]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2018-05-24

On-Brand Devices [INNO Implant System-Ball Abutment]

• 08809471724673: 2SBAT454
• 08809471724666: 2SBAT444
• 08809471724659: 2SBAT434
• 08809471724642: 2SBAT424
• 08809471724635: 2SBAT414