FAST SPLINT MATRIX

GUDID 66714700001194

COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM)

Synca Marketing Inc

Dental reinforcing fibre

• Primary Device ID: 66714700001194
• NIH Device Record Key: c764317b-2f2e-432e-aa68-ac4bb50c8b60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAST SPLINT MATRIX
• Version Model Number: FSM08
• Company DUNS: 247111768
• Company Name: Synca Marketing Inc
• Device Count: 5
• 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

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667147001194 [Unit of Use]
GS1	66714700001194 [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 [FAST SPLINT MATRIX]

• 66714700001255: BOND RESIN (5ML)
• 66714700001231: SILICONE WIDE APPLICATION TIPS (100)
• 66714700001217: ADHESIVE WAX STRIPS FOR FIBERS 1:4 (8-55MM)
• 66714700001200: COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM)
• 66714700001194: COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM)
• 00667147100224: SILICONE WIDE APPLICATION TIPS (100)
• 00667147100200: ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM)
• 00667147100194: COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM)
• 00667147100187: COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM)