COMPONEER CLASS V 60018422

GUDID J006600184220

Coltène/Whaledent AG

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Primary Device ID	J006600184220
NIH Device Record Key	5058e667-1aa4-43d6-85ad-d310cff1bb64
Commercial Distribution Status	In Commercial Distribution
Brand Name	COMPONEER CLASS V
Version Model Number	60018422
Catalog Number	60018422
Company DUNS	480017482
Company Name	Coltène/Whaledent AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com
Phone	+41717575300
Email	info.ch@coltene.com

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature	Between 15 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *KEEP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J006600184220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112168

FDA Product Code

EBF	Material, Tooth Shade, Resin

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2023-07-13
Device Publish Date	2016-08-15

On-Brand Devices [COMPONEER CLASS V]

J006600184220	60018422
J006600180560	60018056
J006600180270	60018027
J006600180250	60018025
J006600180240	60018024
J006600180230	60018023
J006600180180	60018018
J006600180170	60018017
J006600180160	60018016
J006600180150	60018015
J006600180090	60018009
J006600187730	60018773
J006600180400	60018040
J006600180290	60018029
J006600180280	60018028
J006600180260	60018026
J006600180220	60018022
J006600180210	60018021
J006600180200	60018020
J006600180190	60018019
J006600180130	60018013
J006600180120	60018012
J006600180110	60018011
J006600180100	60018010