20 MINUTES 1032100

GUDID D8451032100

LIQUID 20 MINUTES, 250 ml

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451032100
• NIH Device Record Key: 257deb08-3254-4625-b5c5-9aef47b514a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20 MINUTES
• Version Model Number: 1032100
• Catalog Number: 1032100
• 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	D8451032100 [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: 2018-05-02

On-Brand Devices [20 MINUTES]

• D8451032200: LIQUID 20 MINUTES, 1 L
• D8451032100: LIQUID 20 MINUTES, 250 ml