CST

GUDID 00667147000067

FIBER FORCE CST DENTURE COMPLETE KIT

Synca Marketing Inc

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: 00667147000067
• NIH Device Record Key: 5c1d4c33-cb8e-4fa6-acde-e19204ec90f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CST
• Version Model Number: CST50
• 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: true
• 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: 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

• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 Millimeter
• Length: 450 Millimeter
• Total Volume: 5 Milliliter
• Total Volume: 3 Milliliter
• Length: 300 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667147000067 [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)