BRILLIANT EverGlow Flow 60019751

GUDID J00660019751

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in several shades. 1 Syringe a 2g Opaque OA2

Coltène/Whaledent AG

Dental composite resin
Primary Device IDJ00660019751
NIH Device Record Key5ea1f755-267d-4322-be4d-9a0c0104f04a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRILLIANT EverGlow Flow
Version Model Number60019751
Catalog Number60019751
Company DUNS480017482
Company NameColtène/Whaledent AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41717575300
Emailinfo.ch@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage: 4-23 °C / 39-73 °F.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00660019751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-08
Device Publish Date2019-06-28

On-Brand Devices [BRILLIANT EverGlow Flow]

J00660019760BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019758BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019757BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019756BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019755BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019754BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019753BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
J00660019752BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in sev
J00660019751BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev

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