Manufacturer registered with FDA
Burbank Dental Lab
Burbank, CA, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Burbank Dental 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | AB Dental AbutmentBDL ABBDL KeystoneKeystone AbutmentS.I.N. AbutmentsSmart OneTerrats Abutment | 2016 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Myerson EMATap III | 2015 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | — | 2026 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | — | 2026 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | — | 2026 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | — | 2026 |
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
Burbank Dental 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).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2024 | K232735 | EMA 3D | EMA-Sleep Inc | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Burbank Dental LaboratoryFDA reg. 3007233968 | Burbank, CA, United States | Contract manufacturer, Manufacturer |
Other names on FDA records
Burbank Dental Laboratory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043629). 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.