Data / Medical devices / United States / Dental Engineering Laboratories, LLC
Dental Engineering Laboratories, LLC: FDA-registered device maker in Goleta, CA, United States, 1 510(k) clearance
Dental Engineering Laboratories, LLC is registered with the FDA (registration 3013022399) in Goleta, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013022399
- Address
- 315 Bollay Drive Suite 150, Goleta, CA, United States, 93117
- Owner or operator
- Dental Engineering Laboratories (10052682)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- September 24, 2016
- Registered through
- 2026
- Brand names listed
- GG-3M, TFRK, TFRK-12, TFRK-6, TFRK-CS, TFRK-GPR, TFRK-L, TFRK-L+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dental Implant Surgical Tray | OFY | 1 | Specification developer | accessdata.fda.gov |
| Endodontic Kit | NYD | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 29, 2013 | K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | ELC | Substantially Equivalent | American Eagle Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instruments, Dental Hand
- All makers of Scaler, Ultrasonic
- All makers of Endodontic Kit
- All makers of Bur, Dental
- All makers of Dental Implant Surgical Tray
- All makers of Explorer, Operative
Updated March 29, 2013. 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.