Data / Medical devices / United States / Steiner Biotechnology
Steiner Biotechnology: FDA-registered device maker in Henderson, NV, United States, 5 510(k) clearances
Steiner Biotechnology is registered with the FDA (registration 3005138409) in Henderson, NV, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 6, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005138409
- Address
- 1051 Olsen St # 3611, Henderson, NV, United States, 89011
- Owner or operator
- Steiner Biotechnology LLC (9072756)
- Roles
- Manufacturer
- First device listed
- February 16, 2007
- Registered through
- 2026
- Brand names listed
- Oral Bond, OsseoConduct, Sinus Graft, Socket Graft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 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 6, 2016 | K142130 | ORAL BOND | EMA | Substantially Equivalent | Steiner Laboratories | accessdata.fda.gov |
| January 27, 2012 | K113049 | SOCKET GRAFT | LYC | Substantially Equivalent | Steiner Laboratories | accessdata.fda.gov |
| October 26, 2010 | K101718 | OSSEOCONDUCT | LYC | Substantially Equivalent | Steiner Laboratories Div of Steiner Healthcare, LLC | accessdata.fda.gov |
| November 28, 2006 | K063010 | REGEN BIOCEMENT | LYC | Substantially Equivalent | Steiner Laboratories | accessdata.fda.gov |
| June 9, 2006 | K052493 | SOCKET GRAFT | LYC | Substantially Equivalent | Steiner Laboratories | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2016. 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.