Data / Medical devices / United States / Synca Direct
Synca Direct: FDA-registered device maker in Champlain, NY, United States, 1 510(k) clearance
Synca Direct is registered with the FDA (registration 3006084069) in Champlain, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 27, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006084069
- Address
- 1320 State Route 9, Champlain, NY, United States, 12919
- Owner or operator
- Synca Marketing (10034495)
- Roles
- Repackager or relabeler
- First device listed
- August 7, 2014
- Registered through
- 2026
- Brand names listed
- Biolight TEMP Crown and Bridge
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 27, 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
Updated December 27, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.