FAST SPLINT MATRIX
GUDID 66714700001255
BOND RESIN (5ML)
Synca Marketing Inc
Dental prosthesis restorative material, unfilled resin| Primary Device ID | 66714700001255 |
| NIH Device Record Key | aa3e1422-da24-40e0-b805-583ae1427617 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FAST SPLINT MATRIX |
| Version Model Number | FSM24 |
| 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 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@xx.x | |
| Phone | 1-800-667-9622 |
| xx@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 | 66714700001255 [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) |
| 10667147100221 | SILICONE WIDE APPLICATION TIPS (100) |
| 10667147100207 | ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM) |
| 10667147100191 | COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM) |
| 10667147100184 | COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM) |
Trademark Results [FAST SPLINT MATRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FAST SPLINT MATRIX 85822655 4557630 Live/Registered |
SYNCA MARKETING INC. 2013-01-14 |
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