BRILLIANT COMPONEER 60023131

GUDID J00660023131

BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite enamel shells for direct veneering. BRILLIANT COMPONEER upper jaw M bleach translucent 21.

Coltène/Whaledent AG

Dental veneer, custom-made
Primary Device IDJ00660023131
NIH Device Record Keyab054b7d-7e1d-4ac9-85ee-23e911a52a2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRILLIANT COMPONEER
Version Model Number60023131
Catalog Number60023131
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
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com
Phone+41717575300
Emailinfo.ch@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or other heat sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 4-23 °C / 39-73 °F

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00660023131 [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 Date2020-02-17
Device Publish Date2020-02-07

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