ACCOLADE PV 91235

GUDID 00816594020337

ACCOLADE,PV,TRY-IN,XTRA LT,3GM

DANVILLE MATERIALS, LLC

Light-cured dental restorative composite resin

• Primary Device ID: 00816594020337
• NIH Device Record Key: 61c02f2f-56b2-4a30-8079-e62f56b1d989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCOLADE PV
• Version Model Number: 91235
• Catalog Number: 91235
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 74 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816594020337 [Primary]

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, 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 [ACCOLADE PV]

• 00816594020375: ACCOLADE,PV,YELLOW,3GM
• 00816594020368: ACCOLADE,PV,XLUCENT,5GM
• 00816594020351: ACCOLADE,PV,WHITE,OPAQUER,3GM
• 00816594020344: ACCOLADE,PV,TRY-IN,YELLOW,3GM
• 00816594020337: ACCOLADE,PV,TRY-IN,XTRA LT,3GM
• 00816594020320: ACCOLADE,PV,TRY-IN,WHT,OPQ,3GM
• 00816594020313: ACCOLADE,PV,TRY-IN,TRANSL.5GM
• 00816594020306: ACCOLADE,PV,TRY-IN,LIGHT,3GM
• 00816594020290: ACCOLADE,PV,TRY-IN,BROWN,3GM
• 00816594020283: ACCOLADE,PV,TRY-IN KIT
• 00816594020276: ACCOLADE,PV,LIGHT,3GM
• 00816594020269: ACCOLADE,PV,EXTRA,LIGHT,3GM
• 00816594020252: ACCOLADE,PV,BROWN,3GM