SureCure

GUDID D918SCA2

Orthodontic appliance system, progressive FDA PT: HJDC

Digital Orthodontic Care

Orthodontic appliance system, progressive

• Primary Device ID: D918SCA2
• NIH Device Record Key: fc0b0d96-ad4d-404a-9fca-ae3d5142c53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCure
• Version Model Number: Aligners
• Company DUNS: 203697156
• Company Name: Digital Orthodontic Care
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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
HIBCC	D918SCA0 [Primary]
HIBCC	D918SCA1 [Package]; Contains: D918SCA0; Package: Bag [2 Units]; In Commercial Distribution
HIBCC	D918SCA2 [Package]; Contains: D918SCA1; Package: Box [34 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182329

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-16
• Device Publish Date: 2019-07-08