INNO Submerged Implant System-Healing Abutment

GUDID 08809471723287

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: 08809471723287
• NIH Device Record Key: 27f6e813-e836-452b-b509-0f5b084cdd13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Submerged Implant System-Healing Abutment
• Version Model Number: 2HSR421
• 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	08809471723287 [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

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

[08809471723287]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-10-28

On-Brand Devices [INNO Submerged Implant System-Healing Abutment]

• 08809471723553: 2HS6572
• 08809471723546: 2HS6552
• 08809471723539: 2HS6542
• 08809471723522: 2HS6532
• 08809471723515: 2HS6522
• 08809471723508: 2HS6511
• 08809471723492: 2HS5572
• 08809471723485: 2HS5552
• 08809471723478: 2HS5542
• 08809471723461: 2HS5532
• 08809471723454: 2HS5522
• 08809471723447: 2HS5511
• 08809471723430: 2HS4572
• 08809471723423: 2HS4552
• 08809471723416: 2HS4542
• 08809471723409: 2HS4532
• 08809471723393: 2HS4522
• 08809471723386: 2HS4511
• 08809471723379: 2HSW552
• 08809471723362: 2HSW542
• 08809471723355: 2HSW532
• 08809471723348: 2HSW522
• 08809471723331: 2HSW521
• 08809471723324: 2HSR452
• 08809471723317: 2HSR442
• 08809471723300: 2HSR432
• 08809471723294: 2HSR422
• 08809471723287: 2HSR421
• 08809471723270: 2HSM352
• 08809471723263: 2HSM342
• 08809471723256: 2HSM332
• 08809471723249: 2HSM322
• 08809471723232: 2HSM321