FIBER FORCE

GUDID 66714700001101

PINK MESH (2-53MMX80MM)

Synca Marketing Inc

Dental reinforcing fibre

• Primary Device ID: 66714700001101
• NIH Device Record Key: 57b7b1ad-06d4-49b2-952b-906a9cb9032e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER FORCE
• Version Model Number: FF08004
• Company DUNS: 247111768
• Company Name: Synca Marketing Inc
• Device Count: 2
• 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: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X
• Phone: 1-800-667-9622
• Email: XX@XX.X

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667147001101 [Unit of Use]
GS1	66714700001101 [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: 2016-10-04

On-Brand Devices [FIBER FORCE]

• 66714700001125: PINK UD FIBERS (2-150MM)
• 66714700001118: WHITE BRAIDED ROPE 2MM (2-150MM)
• 66714700001101: PINK MESH (2-53MMX80MM)
• 66714700001095: PINK BRAIDED ROPE 2MM (2-150MM)
• 66714700001088: PINK BRAIDED ROPE 1MM (2-150MM)
• 00667147100125: PINK UD FIBERS (2-150MM)
• 00667147100118: WHITE BRAIDED ROPE 2MM ( 2-150MM)
• 00667147100101: PINK MESH (2-53MMx80MM)
• 00667147100095: PINK BRAIDED ROPE 2MM (2-150MM)
• 00667147100088: PINK BRAIDED ROPE 1MM (2-150MM)