Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2127132

FEI Number

2127132

Entity Name

ENOVA ILLUMINATION, INC

City/State/Country

Minneapolis, MN, US

Establishment Address

6305 Sandburg Rd., Suite 100, Minneapolis, MN 55427, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Enova Illumination Inc. (Owner Number: 2127132)

Owner / Operator Contact Address

6305 Sandburg Rd, Suite 100, Minneapolis, MN 55427, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQY	Locator, Root Apex	Unknown	Class U	N/A	2022-09-07
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2006-01-10
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2022-09-07
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2022-09-07
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2022-09-07
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-11-25
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2017-12-12

Official Correspondent

Jeremy Ward

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Enova Illumination Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

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3012477813	Kerr Corporation	Pomona, CA, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2127132. Last updated year: 2026. Please use registration number 2127132 when referencing this establishment in official correspondence.