INNO SLA Submerged Implant System-Healing Abutment

GUDID 08800016125474

Cowellmedi Co.,Ltd

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800016125474
• NIH Device Record Key: 7637ab17-ad82-46de-8d9a-fa2b33eb1a81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO SLA Submerged Implant System-Healing Abutment
• Version Model Number: VUHN7522
• 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	08800016125474 [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

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

Moist Heat or Steam Sterilization

[08800016125474]

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-Healing Abutment]

• 08800016126310: VUHH6512
• 08800016126303: VUHH6522
• 08800016126297: VUHH6532
• 08800016126280: VUHH6542
• 08800016126273: VUHH6552
• 08800016126266: VUHH6572
• 08800016126259: VUHH7512
• 08800016126242: VUHH7522
• 08800016126235: VUHH7532
• 08800016126228: VUHH7542
• 08800016126211: VUHH7552
• 08800016126204: VUHH7572
• 08800016126198: VUHH8512
• 08800016126181: VUHH8522
• 08800016125696: VUHH8532
• 08800016125689: VUHH8542
• 08800016125672: VUHH8552
• 08800016125665: VUHH8572
• 08800016125658: VUHH9512
• 08800016125641: VUHH9522
• 08800016125634: VUHH9532
• 08800016103670: 2HS9532
• 08800016103663: 2HS8532
• 08800016103656: 2HS7532
• 08800016126174: VUHN7542
• 08800016126167: VUHN7552
• 08800016126150: VUHN7572
• 08800016126143: VUHN8512
• 08800016126136: VUHN8522
• 08800016126129: VUHN8542
• 08800016126112: VUHN8552
• 08800016126105: VUHN8572
• 08800016126099: VUHN9512
• 08800016126082: VUHN9522
• 08800016126075: VUHN9532
• 08800016126068: VUHN9542
• 08800016126051: VUHN9552
• 08800016126044: VUHN9572
• 08800016126037: VUHN8612
• 08800016126020: VUHN8622
• 08800016126013: VUHN8632
• 08800016126006: VUHN8642
• 08800016125993: VUHN8652
• 08800016125986: VUHN8672
• 08800016125627: VUHH9542
• 08800016125610: VUHH9552
• 08800016125603: VUHH9572
• 08800016125597: VUHH8612
• 08800016125580: VUHH8622
• 08800016125573: VUHH8632