DP-HC 1012100

GUDID D8451012100

LIQUID DP-HC, 250 ml

Denplus Inc

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• Primary Device ID: D8451012100
• NIH Device Record Key: 5695cd54-e376-43bd-96e3-e92dfbaa0afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DP-HC
• Version Model Number: 1012100
• Catalog Number: 1012100
• Company DUNS: 202016064
• Company Name: Denplus Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	D8451012100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991996

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-30

On-Brand Devices [DP-HC]

• D8451012200: LIQUID DP-HC, 1L
• D8451012100: LIQUID DP-HC, 250 ml