Premium Tray 1121312

GUDID D8451121312

Cold-cured acrylic resin, White, 11.3 kg

Denplus Inc

Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material Dental impression tray material

• Primary Device ID: D8451121312
• NIH Device Record Key: 403871dc-5282-4bf5-940c-5b1577beff91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Tray
• Version Model Number: 1121312
• Catalog Number: 1121312
• Company DUNS: 202016064
• Company Name: Denplus Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8451121312 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2021-09-29
• Device Publish Date: 2021-09-21

On-Brand Devices [Premium Tray]

• D8451121315: Cold-Cured Acrylic Resin, Blue, 11.3 kg
• D8451121314: Cold-cured acrylic resin, Pink, 11.3 kg
• D8451121313: Cold-cured acrylic resin, Yellow, 11.3 kg
• D8451121312: Cold-cured acrylic resin, White, 11.3 kg
• D8451121215: Cold-cured acrylic resin, Blue, 2.3 kg
• D8451121214: Cold-cured acrylic resin, Pink, 2.3 kg
• D8451121213: Cold-cured acrylic resin, Yellow, 2.3 kg
• D8451121212: Cold-cured acrylic resin, White, 2.3 kg
• D8451121115: Cold-cured acrylic resin, Blue, 454 g
• D8451121114: Cold-cured acrylic resin, Pink, 454 g
• D8451121113: Cold-cured acrylic resin, Yellow, 454 g
• D8451121112: Cold-cured acrylic resin, White, 454 g