FDA Registration
Active
🇺🇸 United States
ENOVA ILLUMINATION, INC
Reg #: 2127132
·
FEI: 2127132
·
Expires 2026
Products
10
Proprietary Names
55
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- ENOVA ILLUMINATION, INC
- Registration Number
- 2127132
- FEI Number
- 2127132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6305 Sandburg Rd., Suite 100
- City
- Minneapolis
- State
- MN
- ZIP
- 55427
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181087
Owner / Operator
- Firm Name
- Enova Illumination Inc.
- Operator Number
- 2127132
- Address
- 6305 Sandburg Rd, Suite 100
- City
- Minneapolis
- State
- MN
- Postal Code
- 55427
- Country
- US
- Correspondent
- Jeremy H Ward
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Locator, Root Apex | LQY | Class U | Unknown | No | 2022-09-07 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2006-01-10 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2022-09-07 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2022-09-07 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2022-09-07 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-11-25 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2017-12-12 |
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2020-09-08 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2022-09-07 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2023-06-07 |
Proprietary Names
Apex Locater
XLT-125A
XLT-225A
XLT-105F
XLT-ENT-A40
PLT-165A
XLT-85F
PP1.5 Power Pack
FS3 Power Pack
PP4 Power Pack
PLT-ENT-30A
PLT-80F
PP2 Power Pack
PLT-100A
PLT-60F
Quantum Warm (PLT-175)
Qubit Warm (PLT-80F)
Quasar Warm (PLT-115)
Qubit Cool (XLT-105F)
Quantum Cool (XLT-250)
Quasar Cool (XLT-150)
Axis Light
Activ Battery
PP1.5 Elite Power Pack
Quest
QOSMIC
Activ Elite Battery
Axis Elite Light
Qubit Pro
PP4+ Power Pack
QOSMIC Battery Pack
Piezo Surgery
Endo Motor
Motranser
AC-VUE 2.5, MDA-Vue 2.8, SM-Vue 2.8, MD-Vue 2.8, XG-Vue 2.8, XG-Vue 3.8
Vizix 2.5, Vizix 3, Vizix 3.5
Vizix Prismatic 3.5, Vizix Prismatic 4.5, Vizix Prismatic 5.5
DFK Angled Loupes 3x, DFK Angled Loupes 4x, DFK Angled Loupes 5x
DFK Air Angled Loupes 3x, DFK Air Angled Loupes 4x, DFK Air Angled Loupes 5x
Vizix Ergo 3.5, Vizix Ergo 4.5, Vizix Ergo 5.5
Micro Ergo Elite 3.5x, Micro Ergo Elite 5x
OMS2380 Surgical Microscope
OMS2360 Surgical Microscope
OMS3200 Surgical Microscope
OMS2350 Surgical Microscope
OMS1950 Surgical Microscope
OMS2380 R2 Surgical Microscope
OMS3200Pro Surgical Microscope
OMS3200 R2 Surgical Microscope
OMS3500 Surgical Microscope
Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E
Broken Removal Kit 25mm
Dental Tweezer (Crab-Claw-Shaped) Including One Cleaning Connector f 0.9
Broken Removal Kit 21mm,
Broken Removal Kit 17mm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device