Data / Medical devices / United States / Trident Lab Inc.
Trident Lab Inc.: FDA-registered device maker in Hawthorne, CA, United States, 4 510(k) clearances
Trident Lab Inc. is registered with the FDA (registration 2087481) in Hawthorne, CA, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 26, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2087481
- FEI number
- 1000253567
- Address
- 12000 Aviation BLVD., Hawthorne, CA, United States, 90250
- Owner or operator
- National Dentex LLC (9054557)
- Roles
- Repackager or relabeler
- First device listed
- September 9, 2008
- Registered through
- 2027
- Brand names listed
- Base Metal Restoration, Biotenta Customized Abutment - Hybrid, Biotenta Customized Abutment - Titanium, Full Dentures, Noble Metal Restoration, Partial Dentures, Porcelian fused to metal, Preat Abutments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dentures, Full | NSL | N | Repackager or relabeler | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 26, 2022 | K220823 | Preat Abutments | NHA | Substantially Equivalent | Preat Corporation | accessdata.fda.gov |
| March 18, 2019 | K183518 | Preat Abutments | NHA | Substantially Equivalent | Preat Corporation | accessdata.fda.gov |
| December 1, 2015 | K151295 | Biodenta Customized Abutment - Titanium | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| July 2, 2015 | K150296 | Biodenta Customized Abutment-Hybrid | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Implant, Endosseous, Root-Form
- All makers of Crown, Preformed
- All makers of Dentures, Partial
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated October 26, 2022. 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.