Pure PMMA Disc 371

GUDID 04806532673714

Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until perman

QUEST DENTAL MATERIAL CORPORATION

Dental crown/bridge, temporary Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge

• Primary Device ID: 04806532673714
• NIH Device Record Key: 25680679-efd7-45b2-960f-212597a01527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure PMMA Disc
• Version Model Number: Shade:BL3, Thickness:30mm
• Catalog Number: 371
• 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

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 98 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04806532673714 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-27

On-Brand Devices [Pure PMMA Disc]

• 04806532673912: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673905: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673899: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673882: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532673875: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 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