Healing Cap

GUDID 08806169097729

DIO Corporation

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169097729
• NIH Device Record Key: 1945e61a-2c3e-4d52-81f2-6dddb27a5e95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Cap
• Version Model Number: HCI 60704[H]
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169097729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122519

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-19

On-Brand Devices [Healing Cap]

• 08806169097729: HCI 60704[H]
• 08800049245361: HCI 65704[H]
• 08800049245330: HCI 48504[H]