FDA Registration
Active
🇨🇦 Canada
Fast Splint Matrix 1:1 compressible hybrid bulk refill (40)
Reg #: 3006697692
·
FEI: 3006697692
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SYNCA MARKETING
- Registration Number
- 3006697692
- FEI Number
- 3006697692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 337 Marion
- City
- Le Gardeur Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K102207
Owner / Operator
- Firm Name
- Synca Marketing
- Operator Number
- 10034495
- Address
- 337 Marion
- City
- Le Gardeur
- State
- Quebec
- Postal Code
- J5Z 4W8
- Country
- CA
- Correspondent
- Patrizia Manna
US Agent
- Business Name
- Freeport Forwarding
- Contact Name
- Stephanie Brown
- Address
- 1320 Route State 9
- City
- Champlain
- State
- NY
- ZIP
- 12919
- Country
- US
- [email protected]
- Phone
- 518 2988582
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2010-12-06 |
Proprietary Names
Fast Splint Matrix 1:1 compressible hybrid bulk refill (40)
Fiber Force CST pink fiber hybrid 1:6 450mm
Fast Splint Matrix silicone impression material (2-50ml) + tips
Fast Splint Matrix silicone wide application tips (100)
Fast Splint Matrix silicone impression mixing tips
Fast Splint Matrix Intro kit 1:1
Fiber Force CST Temporary support pillar drill
Fiber Force CST Bond resin 5ml
Fast Splint Matrix compressible hybrid fibers 1:4 (5-55mm)
Fast Splint Matrix 1mm compressible bulk refill (40)
Fiber Force CST Flow pink resin (3ml) with tips (4)
Fast Splint Matrix compressible hybrid fibers 1:1 (5-55mm)
Fiber Force CST pink fiber hybrid 1:4 300mm
Fast Splint Matrix adhesive wax strips (8-55mm)
Fiber Force CST denture complete kit
Fast Splint Matrix matrix positioning tips (5)
Fast Splint Matrix Flow light cure composite (3ml)
Fiber Force CST Temporary support pillars (10)
Fast Splint Matrix Intro kit 1mm
Fast Splint Matrix compressible hybrid fibers 1mm (5-55mm)
Fast Splint Matrix 1:4 compressible hybrid refill (40)
Fast Splint Matrix Intro kit 1:4
Fast Splint Matrix bond resin (5ml)
Fiber Force CST Denture refill kit
Fiber Force pink mesh (2 - 53mm x 80mm)
Fiber Force Pink/white Braided Rope (1mmx150mm)
Fiber Force Light Cure Pink/white Resin (3ml + 4tips)
Fiber Force Pink/white Braided Rope (2mmx150mm)
Fiber Force
Fiber Force Pink/white UD Fiber (2mmx150mm)
Fiber Force Disk
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device