TempoSIL 2 6728

GUDID J00667280

Coltène/Whaledent AG

Temporary dental crown/bridge
Primary Device IDJ00667280
NIH Device Record Keyd227f6d2-b748-4a5a-b05e-220c93e439cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempoSIL 2
Version Model Number6728
Catalog Number6728
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 Usefalse
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
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

Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00667280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-29
Device Publish Date2016-08-15

On-Brand Devices [TempoSIL 2]

J006673006730
J006672906729
J006672806728
J006672706727
J006368603686

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