CST

GUDID 66714700001033

FIBER FORCE CST BOND RESIN (5ML)

Synca Marketing Inc

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: 66714700001033
• NIH Device Record Key: 1aa5181a-394f-4594-a7af-dbafcc0a39e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CST
• Version Model Number: CST16
• 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: 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.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X
• Phone: 1-800-667-9622
• Email: XXX@XX.X

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	66714700001033 [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

Devices Manufactured by Synca Marketing Inc

• 00667147100088 - FIBER FORCE: 2021-08-03 PINK BRAIDED ROPE 1MM (2-150MM)
• 00667147100095 - FIBER FORCE: 2021-08-03 PINK BRAIDED ROPE 2MM (2-150MM)
• 00667147100101 - FIBER FORCE: 2021-08-03 PINK MESH (2-53MMx80MM)
• 00667147100118 - FIBER FORCE: 2021-08-03 WHITE BRAIDED ROPE 2MM ( 2-150MM)
• 00667147100125 - FIBER FORCE: 2021-08-03 PINK UD FIBERS (2-150MM)
• 00667147100187 - FAST SPLINT MATRIX: 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM)
• 00667147100194 - FAST SPLINT MATRIX: 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM)
• 00667147100200 - FAST SPLINT MATRIX: 2021-08-03 ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM)