DP20 1021100

GUDID D8451021100

DP20, CLR, 454 g

Denplus Inc

Dental appliance fabrication material, cured

• Primary Device ID: D8451021100
• NIH Device Record Key: 70bb69f4-fb60-4f28-9c74-ce2ef68a8b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DP20
• Version Model Number: 1021100
• Catalog Number: 1021100
• 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	D8451021100 [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 [DP20]

• D8451021309: DP20, CUSTOM, 11.3 kg
• D8451021300: DP20, CLR, 11.3 kg
• D8451021200: DP20, CLR, 2.3 kg
• D8451021100: DP20, CLR, 454 g