Data / Medical devices / United States / Smartguard RX Inc
Smartguard RX Inc: FDA-registered device maker in Layton, UT, United States, 2 510(k) clearances
Smartguard RX Inc is registered with the FDA (registration 3013652641) in Layton, UT, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013652641
- Address
- 201 East 2150 North, Unit E, Layton, UT, United States, 84041
- Owner or operator
- SmartGuard Rx Inc (10055164)
- Roles
- Specification developer
- First device listed
- June 14, 2017
- Registered through
- 2026
- Brand names listed
- SmartGuard Anti-Snore Device, SmartGuard Dental Guard, SmartGuard Elite, SmartGuard Elite Night Guard, SmartGuard Night Guard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| 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 23, 2021 | K200657 | SmartGuard Anti-Snoring Device | LRK | Substantially Equivalent | Smartguard Rx, Inc. | accessdata.fda.gov |
| March 14, 2013 | K123161 | SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE | MQC | Substantially Equivalent | Smartguard, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Over-The-Counter
- All makers of Mouthguard, Prescription
- All makers of Device, Anti-Snoring
Updated August 23, 2021. 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.