Manufacturer registered with FDA
Apex Dental Sleep Lab
La Mesa, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Apex Dental Sleep Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMAEMA 3DKavaMMRNAOasys Oral/Nasal Airway SystemPanthera D-SADTAP | 2017 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMA 3DKavaMMRNA | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Apex Dental Sleep Lab lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: EMA-Sleep Inc (1), Sketchpad Innovations, LLC (1), Panthera Dental Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2024 | K232735 | EMA 3D | EMA-Sleep Inc | LRK Anti-Snoring Device |
| 13 Feb 2019 | K182661 | Kava and Kava with Herbst | Sketchpad Innovations, LLC | LRK Anti-Snoring Device |
| 15 Dec 2014 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| APEX DENTAL SLEEP LABFDA reg. 3012716038 | La Mesa, CA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055016). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.