Premium Tray 1121213

GUDID D8451121213

Cold-cured acrylic resin, Yellow, 2.3 kg

Denplus Inc

Dental impression tray material

• Primary Device ID: D8451121213
• NIH Device Record Key: a501c059-d7c1-44b1-8333-7e5fea428782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Tray
• Version Model Number: 1121213
• Catalog Number: 1121213
• 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	D8451121213 [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