SwissTEC A-Sil 5501

GUDID J00655010

Coltène/Whaledent AG

Silicone dental impression material
Primary Device IDJ00655010
NIH Device Record Key45849316-c066-4b07-a3c8-e41140cba39d
Commercial Distribution Discontinuation2021-11-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSwissTEC A-Sil
Version Model Number5501
Catalog Number5501
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

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
Storage Environment TemperatureBetween 15 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00655010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-22
Device Publish Date2016-08-15

On-Brand Devices [SwissTEC A-Sil]

J006550605506
J006550105501

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