Healing abutment HC2

GUDID 07290018434277

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system

• Primary Device ID: 07290018434277
• NIH Device Record Key: 95e67e74-4706-4dc5-bf1d-b7ba95ae6482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing abutment
• Version Model Number: 2mm
• Catalog Number: HC2
• Company DUNS: 531825934
• Company Name: MEDICAL SYSTEMS AND DEVICES INTERNATIONAL 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: true
• 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	07290018434277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191443

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

[07290018434277]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [Healing abutment]

• 07290018434321: 7mm
• 07290018434314: 6mm
• 07290018434307: 5mm
• 07290018434291: 4mm
• 07290018434284: 3mm
• 07290018434277: 2mm