Data / Medical devices / United States / Snowrock USA
Snowrock USA: FDA-registered device maker in Buford, GA, United States, 1 510(k) clearance
Snowrock USA is registered with the FDA (registration 3010368334) in Buford, GA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 26, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010368334
- Address
- 4195 S Lee St Ste K, Buford, GA, United States, 30518
- Owner or operator
- Snowrock USA (10045607)
- Roles
- Repackager or relabeler
- First device listed
- December 6, 2013
- Registered through
- 2026
- Brand names listed
- Snow Rock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Floss, Dental | JES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | 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 |
|---|---|---|---|---|---|---|
| July 26, 2013 | K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS | EBI | Substantially Equivalent | Dentsoll, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tip, Rubber, Oral Hygiene
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Floss, Dental
Updated July 26, 2013. 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.