TURBO TEMP 3 93326

GUDID 00816594020955

TURBO TEMP3,B1,FA

DANVILLE MATERIALS, LLC

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

• Primary Device ID: 00816594020955
• NIH Device Record Key: b2e9bdd9-ecbb-4e7b-8dd8-bc4ce85e1201
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TURBO TEMP 3
• Version Model Number: 93326
• Catalog Number: 93326
• Company DUNS: 601302743
• Company Name: DANVILLE MATERIALS, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx
• Phone: +1(760)743-7744
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816594020955 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-22

On-Brand Devices [TURBO TEMP 3]

• 00816594020962: TURBO TEMP3,BLEACH,FA
• 00816594020955: TURBO TEMP3,B1,FA
• 00816594020948: TURBO TEMP3,A3.5,FA
• 00816594020931: TURBO TEMP3,A3,FA
• 00816594020924: TURBO TEMP3,A2,FA
• 00816594020917: TURBO TEMP3,A1,FA