INNO SLA Submerged Implant System-Protect Cap

GUDID 08809471724437

Cowellmedi Co.,Ltd

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809471724437
• NIH Device Record Key: 21c1bda5-10a1-442e-82eb-97980c951ba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO SLA Submerged Implant System-Protect Cap
• Version Model Number: 2SHPC555
• 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	08809471724437 [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

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

[08809471724437]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

On-Brand Devices [INNO SLA Submerged Implant System-Protect Cap]

• 08809471724475: 2SHPC657
• 08809471724468: 2SHPC655
• 08809471724451: 2SHPC654
• 08809471724444: 2SHPC557
• 08809471724437: 2SHPC555
• 08809471724420: 2SHPC554
• 08809471724413: 2SHPC457
• 08809471724406: 2SHPC455
• 08809471724390: 2SHPC454