CST

GUDID 66714700001002

FIBER FORCE CST PINK FIBERS 1:6 HYBRID (450MM)

Synca Marketing Inc

Dental reinforcing fibre

Primary Device ID	66714700001002
NIH Device Record Key	bcf42356-e75f-478f-9ad7-cdc920de82b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	CST
Version Model Number	CST10
Company DUNS	247111768
Company Name	Synca Marketing Inc
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	true
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	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx
Phone	1-800-667-9622
Email	xxx@xx.xx

Device Dimensions

Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter
Length	450 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 12 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	66714700001002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K102207

FDA Product Code

EBI	Resin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-03

On-Brand Devices [CST]

66714700001064	FIBER FORCE CST DENTURE COMPLETE KIT
66714700001026	FIBER FORCE CST FLOW PINK RESIN (3ML)
66714700001019	FIBER FORCE CST PINK FIBERS 1:4 HYBRID (300MM)
66714700001002	FIBER FORCE CST PINK FIBERS 1:6 HYBRID (450MM)
00667147000067	FIBER FORCE CST DENTURE COMPLETE KIT
00667147000029	FIBER FORCE CST FLOW PINK RESIN (3ML)
00667147000012	FIBER FORCE CST PINK FIBERS 1:4 HYBRID (300MM)
00667147000005	FIBER FORCE CST PINK FIBERS 1:6 hybrid (450 MM)