CST

GUDID 00667147000005

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

Synca Marketing Inc

Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre

• Primary Device ID: 00667147000005
• NIH Device Record Key: 97217dfc-cbb5-41a5-9fba-9bff2a48f96a
• 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

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

Operating and Storage Conditions

• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667147000005 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-23
• Device Publish Date: 2021-07-15

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)