Registered with FDA
Enova Illumination Inc.
Minneapolis, MN, 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
- 726 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Enova Illumination Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Enova Illumination Inc. | 6 device types | — | Below |
| Australia | TGA | Manufacturer | Enova Illumination Inc | 8 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Enova Illumination Inc. | 8 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Enova Illumination Inc. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Enova Illumination, INCENOVA ILLUMINATION, LLC | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ENOVA ILLUMINATION, LLCEnova Illumination, Inc. | 3 | 2016–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | ENOVA ILLUMINATION, LLC | 1 | 2015–2015 | 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 Enova Illumination Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Piezo Surgery | 2022 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Motranser | 2024 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Endo Motor | 2022 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Lister | Broken Removal Kit 17mmBroken Removal Kit 21mm,Broken Removal Kit 25mmDental Tweezer (Crab-Claw-Shaped) Including One Cleaning Connector f 0.9 | 2023 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Piezo Surgery | 2022 |
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
Enova Illumination Inc. 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: Guilin Woodpecker Medical Instrument Co., Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | DZI Powered Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENOVA ILLUMINATION, INCFDA reg. 2127132 | Minneapolis, MN, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2127132). 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.