ACCOLADE OP 93597

GUDID 00816594020245

ACCOLADE,OP,TOOTHCOLOR,2GM,FA

DANVILLE MATERIALS, LLC

Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin
Primary Device ID00816594020245
NIH Device Record Key6d01c61e-e2cf-48fb-a9c3-cffca0769d33
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCOLADE OP
Version Model Number93597
Catalog Number93597
Company DUNS601302743
Company NameDANVILLE MATERIALS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)743-7744
Emailxxx@xxx.xxx
Phone+1(760)743-7744
Emailxxx@xxx.xxx
Phone+1(760)743-7744
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 74 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816594020245 [Primary]

FDA Product Code

EBFMATERIAL, TOOTH SHADE, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-22

On-Brand Devices [ACCOLADE OP]

00816594020245ACCOLADE,OP,TOOTHCOLOR,2GM,FA
00816594020092ACCOLADE,OP,WHITE,2GM,FA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.