Data / Medical devices / United States / MN Health, Inc
MN Health, Inc: FDA-registered device maker in Chantilly, VA, United States, 3 510(k) clearances
MN Health, Inc is registered with the FDA (registration 3018047916) in Chantilly, VA, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018047916
- Address
- 14221a Willard Rd Ste 1100, Chantilly, VA, United States, 20151
- Owner or operator
- MN Health Inc (10080654)
- Roles
- Repackager or relabeler
- First device listed
- March 25, 2025
- Registered through
- 2026
- Brand names listed
- raypulp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Resin | KXR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tester, Pulp | EAT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2020 | K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | FRG | Substantially Equivalent | Weihai Xingtai Packaging Products Co., Ltd. | accessdata.fda.gov |
| September 14, 1998 | K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
| November 25, 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Wrap, Sterilization
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Material, Tooth Shade, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Holder, Film, X-Ray
Updated April 15, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.