SwissTEC HydroXtreme 4920

GUDID J00649200

Coltène/Whaledent AG

Silicone dental impression material
Primary Device IDJ00649200
NIH Device Record Key83499e76-824a-4b2a-bf03-d2881a4f1811
Commercial Distribution Discontinuation2021-11-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSwissTEC HydroXtreme
Version Model Number4920
Catalog Number4920
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
HIBCCJ00649200 [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 HydroXtreme]

J006551505515
J006551405514
J0065510LA05510 LA
J006492204922
J006492104921
J00660011365060011365
J00660011362060011362
J00660011356060011356
J00660011349060011349
J00660011200060011200
J00660010926060010926
J006551305513
J006551205512
J006492304923
J006492004920
J006476204762
J006476104761
J006476004760
J006475904759
J006475804758
J006475704757

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