Data / Medical devices / Sweden / Biora AB
Biora AB: FDA-registered device maker in MALMO Skane, Sweden, 2 510(k) clearances and 1 PMA approval
Biora AB is registered with the FDA (registration 9612827) in MALMO Skane, Sweden. It lists 3 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated September 24, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9612827
- FEI number
- 3002806508
- Address
- Medeon Science Park, MALMO Skane, Sweden, S-205-12
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- December 6, 2006
- Registered through
- 2027
- Brand names listed
- STRAUMANN EMDOGAIN, Straumann BoneCeramic, Straumann® PrefGel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biologic Material, Dental | NQA | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Root Canal | KJJ | U | 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 |
|---|---|---|---|---|---|---|
| September 24, 2020 | K201051 | Straumann BoneCeramic | LYC | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| January 12, 2007 | K063812 | STRAUMANN PREFGEL | KJJ | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 30, 1996 | P930021 | BIORA EMDOGAIN(R) | NQA | 34 | September 5, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Synthetic
- All makers of Cleanser, Root Canal
- All makers of Biologic Material, Dental
Updated September 5, 2025. 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.