Healing abutment HC4

GUDID 07290018434291

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 07290018434291
• NIH Device Record Key: 3a732a84-d0eb-4662-82dc-4d9aee43e1d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing abutment
• Version Model Number: 4mm
• Catalog Number: HC4
• 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	07290018434291 [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

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

[07290018434291]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-01
• Device Publish Date: 2024-01-24

On-Brand Devices [Healing abutment]

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