Data / Medical devices / United States / Hiossen, Inc.
Hiossen, Inc.: FDA-registered device maker in Morrisville, PA, United States, 4 510(k) clearances
Hiossen, Inc. is registered with the FDA (registration 3017450159) in Morrisville, PA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017450159
- Address
- 56-58A East Bridge Street, Morrisville, PA, United States, 19067
- Owner or operator
- Hiossen Inc. (10026425)
- Roles
- Manufacturer
- First device listed
- May 2, 2011
- Registered through
- 2026
- Brand names listed
- 3D LAB ANALOG, Bite Impression Coping Driver, Bushing, Convertible Lab Analog, Convertible Pick-Up Guide Pin, Convertible Pick-Up Impression Coping, Convertible Polishing Protector, Convertible Transfer Impression Coping and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 20, 2024 | K240688 | RODIN Titan 3D Resin | EBI | Substantially Equivalent | Belport Company, Inc., Gingi-Pak | accessdata.fda.gov |
| May 29, 2024 | K233389 | EK Digital Abutments | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| October 31, 2018 | K171585 | LUXEN Zr, LUXEN Smile | EIH | Substantially Equivalent | Dentalmax Co., Ltd. | accessdata.fda.gov |
| June 28, 2013 | K123627 | ET SMARTFIT ABUTMENT | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Positioner, Tooth, Preformed
Updated June 20, 2024. 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.