Data / Medical devices / United States / Randmark Dental Products, LLC
Randmark Dental Products, LLC: FDA-registered device maker in Lusby, MD, United States, 1 510(k) clearance
Randmark Dental Products, LLC is registered with the FDA (registration 3009133124) in Lusby, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009133124
- Address
- 284 Elkins Ln, Lusby, MD, United States, 20657
- Owner or operator
- Randmark Dental Products, LLC (10037706)
- Roles
- Specification developer
- First device listed
- August 9, 2011
- Registered through
- 2026
- Brand names listed
- NiteBite¿
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | U | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 5, 2011 | K110468 | FREEWAY COMFORT BITE GUARD | MQC | Substantially Equivalent | Randmark Dental Products, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 5, 2011. 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.