SureCure

GUDID D918SCA2

Orthodontic appliance system, progressive FDA PT: HJDC

Digital Orthodontic Care

Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• 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