Manufacturer registered with FDA
Dental Engineering Laboratories
Goleta, CA, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Dental Engineering Laboratories as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dental Engineering Laboratories | 6 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DENTAL ENGINEERING LABORATORIES, LLC | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dental Engineering Laboratories currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | TFRK-GPRTFRK-LTFRK-L+ | 2017 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | GG-3MTFRK-MT | 2017 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | TFRK-ME | 2017 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | TFRK-12TFRK-6TFRK-SZTip-EZTip-S | 2016 |
| Endodontic KitNYD · Class 2 | — | Maker | TFRK | 2017 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | TFRK-CS | 2018 |
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
Dental Engineering Laboratories 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: Young Innovations Inc (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Mar 2013 | K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | Young Innovations Inc | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dental Engineering Laboratories, LLCFDA reg. 3013022399 | Goleta, CA, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052682). 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.