CST

GUDID 66714700001033

FIBER FORCE CST BOND RESIN (5ML)

Synca Marketing Inc

Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin 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)