Registered with FDA
Synca Marketing
Le Gardeur, Canada. Lists 5 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 55
- 510(k) clearances
- 12010–2010
- Markets registered in
- 21 registrations outside the US
- Establishments
- 2Canada, United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Synca Marketing as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Synca Marketing | 1 clearances | 2010–2010 | Below |
| Australia | TGA | Manufacturer | Synca Marketing | 1 | 2011–2011 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Synca Marketing currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Fast Splint Matrix 1:1 compressible hybrid bulk refill (40)Fast Splint Matrix 1:4 compressible hybrid refill (40)Fast Splint Matrix 1mm compressible bulk refill (40)Fast Splint Matrix adhesive wax strips (8-55mm)Fast Splint Matrix bond resin (5ml)Fast Splint Matrix compressible hybrid fibers 1:1 (5-55mm)Fast Splint Matrix compressible hybrid fibers 1:4 (5-55mm)Fast Splint Matrix compressible hybrid fibers 1mm (5-55mm)Fast Splint Matrix Flow light cure composite (3ml)Fast Splint Matrix Intro kit 1:1 22 moreFast Splint Matrix Intro kit 1:4Fast Splint Matrix Intro kit 1mmFast Splint Matrix matrix positioning tips (5)Fast Splint Matrix silicone impression material (2-50ml) + tipsFast Splint Matrix silicone impression mixing tipsFast Splint Matrix silicone wide application tips (100)Fiber ForceFiber Force CST Bond resin 5mlFiber Force CST denture complete kitFiber Force CST Denture refill kitFiber Force CST Flow pink resin (3ml) with tips (4)Fiber Force CST pink fiber hybrid 1:4 300mmFiber Force CST pink fiber hybrid 1:6 450mmFiber Force CST Temporary support pillar drillFiber Force CST Temporary support pillars (10)Fiber Force DiskFiber Force Light Cure Pink/white Resin (3ml + 4tips)Fiber Force pink mesh (2 - 53mm x 80mm)Fiber Force Pink/white Braided Rope (1mmx150mm)Fiber Force Pink/white Braided Rope (2mmx150mm)Fiber Force Pink/white UD Fiber (2mmx150mm)Tender Fiber | 2010 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Tender Ortho Bond-Ena Bond-Ena Etch | 2010 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Splintvac | 2011 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Biolight TEMP Crown and Bridge | 2014 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Biolight Advanced Fiber PostBiolight Drill FreeBiolight Dual kitBiolight Dual reamer #0.5Biolight Dual reamer #1Biolight Dual reamer #2Biolight Dual reamer #3Biolight Dual refill #0.5Biolight Dual refill #1Biolight Dual refill #2 10 moreBiolight Dual refill #3Biolight ST kitBiolight ST reamer 1.20mmBiolight ST reamer 1.35mmBiolight ST reamer 1.50mmBiolight ST reamer 10mmBiolight ST refill 1.20mmBiolight ST refill 1.30mmBiolight ST refill 1.50mmBiolight ST refill 10mm | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Synca Marketing as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Nov 2010 | K102207 | FIBER FORCE | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Bio Composants Medicaux (BCM) (1).
Also lists devices cleared under other names
Synca Marketing lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Micerium S.P.A. (2), Kettenbach GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Dec 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | Kettenbach GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 17 Jan 2008 | K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Micerium S.P.A. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Jan 2007 | K063170 | TENDER FIBER | Micerium S.P.A. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Synca DirectFDA reg. 3006084069 | Champlain, NY, United States | Repacker / relabeler |
| SYNCA MARKETINGFDA reg. 3006697692 | Repentigny Quebec, Canada | Foreign exporter, Repacker / relabeler |
Other names on FDA records
Synca Direct
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034495). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.