Data / Medical devices / United States / Burbank Dental Laboratory
Burbank Dental Laboratory: FDA-registered device maker in Burbank, CA, United States, 3 510(k) clearances
Burbank Dental Laboratory is registered with the FDA (registration 3007233968) in Burbank, CA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007233968
- Address
- 2101 Floyd St, Burbank, CA, United States, 91504
- Owner or operator
- Burbank Dental Lab (10043629)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 5, 2015
- Registered through
- 2027
- Brand names listed
- AB Dental Abutment, BDL AB, BDL Keystone, Keystone Abutment, Myerson EMA, S.I.N. Abutments, Smart One, Tap III and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | 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 |
| April 9, 2021 | K203000 | KeyPrint KeySplint Hard | MQC | Substantially Equivalent | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | accessdata.fda.gov |
| November 15, 2019 | K183598 | KeyPrint KeySplint Soft | MQC | Substantially Equivalent | Keystone Industries | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Mouthguard, Prescription
- All makers of Device, Anti-Snoring
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Device, Jaw Repositioning
- All makers of Resin, Denture, Relining, Repairing, Rebasing
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.