Healing Cap

GUDID 07290112280398

Healing Cap

DENTACK IMPLANTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290112280398
• NIH Device Record Key: efd2cfe9-65b4-4cb7-9631-da7bb230283d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Cap
• Version Model Number: HC-300
• Company DUNS: 514897185
• Company Name: DENTACK IMPLANTS 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

Customer Support Contacts

• Phone: +97297660379
• Email: info@pyramidion-is.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290112280398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152188

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290112280398]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-23

On-Brand Devices [Healing Cap]

• 07290112280459: Healing Cap
• 07290112280435: Healing Cap
• 07290112280411: Healing Cap
• 07290112280398: Healing Cap
• 07290112280374: Healing Cap