HIRO Light Cure Pattern, Modeling and Indexing Resin HIRO

GUDID D820HIRO0

Light Cure Pattern, Modeling and Indexing Resin.

DENALI CORPORATION

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: D820HIRO0
• NIH Device Record Key: 83dfed49-a954-4edf-9989-c13af179e1b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIRO Light Cure Pattern, Modeling and Indexing Resin
• Version Model Number: One 3 mL Syringe
• Catalog Number: HIRO
• Company DUNS: 191036107
• Company Name: DENALI CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
HIBCC	D820HIRO0 [Primary]
HIBCC	D820HIRO1 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• EKO: Denture Preformed (Partially Prefabricated Denture)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-09

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• D820ALAYNT3ML0 - AuraLay Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
• D820ALAYOW0 - AuraLay Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
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• D820ALAYXFNT0 - AuraLay XF Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.