Data / Medical devices / United States / Apex Dental Sleep Lab
Apex Dental Sleep Lab: FDA-registered device maker in La Mesa, CA, United States, 3 510(k) clearances
Apex Dental Sleep Lab is registered with the FDA (registration 3012716038) in La Mesa, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012716038
- Address
- 7863 La Mesa Suite 204, La Mesa, CA, United States, 91942
- Owner or operator
- Apex Dental Sleep Lab (10055016)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 24, 2017
- Registered through
- 2026
- Brand names listed
- EMA, EMA 3D, Kava, MMRNA, Oasys Oral/Nasal Airway System, Panthera D-SAD, TAP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K232735 | EMA 3D | LRK | Substantially Equivalent | Ema Sleep Incorporated | accessdata.fda.gov |
| February 13, 2019 | K182661 | Kava and Kava with Herbst | LRK | Substantially Equivalent | Sketchpad Innovations, LLC | accessdata.fda.gov |
| December 15, 2014 | K143244 | The Panthera Anti-Snoring Device | LRK | Substantially Equivalent | Panthera Dental, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Dilator, Nasal
Updated May 3, 2024. 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.