Pure PMMA Disk 258

GUDID 04806532672588

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: 04806532672588
• NIH Device Record Key: fb026536-b1e1-401c-8052-966e1b344108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure PMMA Disk
• Version Model Number: Shade: BL5 Thickness: 25mm
• Catalog Number: 258
• 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: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• Email: h-mori@quest-pure.com
• Phone: 949-870-3985
• 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 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	04806532672588 [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: 2017-12-08

On-Brand Devices [Pure PMMA Disk ]

• 04806532672595: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532672588: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow
• 04806532672571: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crow