Pure PMMA Disc 457

GUDID 04806532674575

Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

QUEST DENTAL MATERIAL CORPORATION

Dental crown/bridge, temporary

• Primary Device ID: 04806532674575
• NIH Device Record Key: 754a96f8-a7af-4109-8a46-5c994cb7a2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure PMMA Disc
• Version Model Number: Shade: MLA2, Thickness: 20mm
• Catalog Number: 457
• Company DUNS: 721541530
• Company Name: QUEST DENTAL MATERIAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com
• Phone: 949-870-3895
• Email: h-mori@quest-pure.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature, avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04806532674575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172281

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [Pure PMMA Disc]

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• 04806532673899: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
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• 04806532673868: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673851: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673844: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673837: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673820: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673813: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673806: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673790: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673783: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673776: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673769: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673752: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673745: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673738: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673721: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673714: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673707: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673691: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673684: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673677: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673660: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673653: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673646: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673639: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673622: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673615: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673608: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673592: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673585: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673578: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673561: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673554: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673547: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673530: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673523: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673516: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673509: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673493: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673486: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673479: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673462: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673455: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673448: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673431: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673424: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow