Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018047916

FEI Number

3018047916

Entity Name

MN Health, Inc

City/State/Country

Chantilly, VA, US

Establishment Address

14221a Willard Rd Ste 1100, Chantilly, VA 20151, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MN Health Inc, (Owner Number: 10080654)

Owner / Operator Contact Address

25589 Creek Run Terrace, Chantilly, VA 20152, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

raypulp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-03-25
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-03-25
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-04-08
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2026-04-24
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-24
KXR	Applicator, Resin	Dental	Class 1	872.3140	2025-04-01
EAT	Tester, Pulp	Dental	Class 2	872.1720	2025-04-01
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2026-04-27

Official Correspondent

Michil Hadad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MN Health 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

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3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018047916. Last updated year: 2026. Please use registration number 3018047916 when referencing this establishment in official correspondence.