Data / Medical devices / United States / Biodent Inc
Biodent Inc: FDA-registered device maker in Encino, CA, United States, 4 510(k) clearances
Biodent Inc is registered with the FDA (registration 2085360) in Encino, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 21, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085360
- FEI number
- 1000306551
- Address
- 16101 Ventura Blvd # 345, Encino, CA, United States, 91436
- Owner or operator
- BIODENT INC /Khachi (10028187)
- Roles
- Specification developer
- First device listed
- January 6, 2009
- Registered through
- 2026
- Brand names listed
- EXTERNAL HEX, INTERNALHEX, NON EXPANDABLE, ULTRATOOTH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| July 21, 2010 | K082573 | SARGON NON-EXPANDABLE DENTAL IMPLANT | DZE | Substantially Equivalent | Sargon Ent., Inc. | accessdata.fda.gov |
| June 23, 1999 | K981141 | SARGON IMMEDIATE LOAD IMPLANT, MODEL D | DZE | Substantially Equivalent | Sargon Ent., Inc. | accessdata.fda.gov |
| May 6, 1996 | K961005 | SARGON IMMEDIATE LOAD IMPLANT | DZE | Substantially Equivalent | Graham & James | accessdata.fda.gov |
| July 8, 1994 | K930071 | SARGON CYLINDRO-BLADE IMPLANT | DZE | Substantially Equivalent | Sargon Ent., Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 21, 2010. 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.