Data / Medical devices / United States / Aeton Medical
Aeton Medical: FDA-registered device maker in Pennsauken, NJ, United States, 1 510(k) clearance
Aeton Medical is registered with the FDA (registration 3007536957) in Pennsauken, NJ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007536957
- Address
- 7115 Airport Hwy, Pennsauken, NJ, United States, 08109
- Owner or operator
- Aeton Medical (10028916)
- Roles
- Specification developer
- First device listed
- March 19, 2009
- Registered through
- 2026
- Brand names listed
- ST Abutment Systems
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 6, 2009 | K083543 | DENOVISMED DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Denovis Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 6, 2009. 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.