Manufacturer registered with FDA
BIODENT INC /Khachi
Encino, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 714 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name BIODENT INC /Khachi as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | BIODENT INC /Khachi | 1 device types | — | Below |
| Colombia | INVIMA | Registration holder | BIODENT CO. LTDBIODENT CO. LTD. | 8 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BIODENT INC. | 2 | 2018–2018 | Pure Global AI |
| China | NMPA | Registration holder | 韩国百旦特株式会社Biodent Co., Ltd. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BIODENT CO., LTD | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Biodent Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | BIODENT CO., LTD. | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What BIODENT INC /Khachi currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | EXTERNAL HEXINTERNALHEXNON EXPANDABLEULTRATOOTH | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
BIODENT INC /Khachi lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sargon Ent., Inc. (3), Graham & James (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Jul 2010 | K082573 | SARGON NON-EXPANDABLE DENTAL IMPLANT | Sargon Ent., Inc. | DZE Root-Form Endosseous Implant |
| 23 Jun 1999 | K981141 | SARGON IMMEDIATE LOAD IMPLANT, MODEL D | Sargon Ent., Inc. | DZE Root-Form Endosseous Implant |
| 6 May 1996 | K961005 | SARGON IMMEDIATE LOAD IMPLANT | Graham & James | DZE Root-Form Endosseous Implant |
| 8 Jul 1994 | K930071 | SARGON CYLINDRO-BLADE IMPLANT | Sargon Ent., Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIODENT INCFDA reg. 2085360 | Encino, CA, United States | Specification developer |
Other names on FDA records
Biodent Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028187). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.