Data / Medical devices / United States / Late Night Concepts Inc. (dba Brux Night Guard)
Late Night Concepts Inc. (dba Brux Night Guard): FDA-registered device maker in Canoga Park, CA, United States, 1 510(k) clearance
Late Night Concepts Inc. (dba Brux Night Guard) is registered with the FDA (registration 3015547648) in Canoga Park, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015547648
- Address
- 8201 Canoga Ave. Unit 9066, Canoga Park, CA, United States, 91309
- Owner or operator
- Late Night Concepts Inc. (DBA Brux Night Guard) (10060442)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 13, 2019
- Registered through
- 2026
- Brand names listed
- Brux Night Guard, DoloPad, Ultrasonic UV Cleaner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Complaint file establishment | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 11, 2019 | K181361 | Brux Night Guard | MQC | Substantially Equivalent | Brux Night Guard | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Pack, Hot Or Cold, Reusable
Updated April 11, 2019. 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.