Data / Medical devices / United States / Titan Implants, Inc.
Titan Implants, Inc.: FDA-registered device maker in Bergenfield, NJ, United States, 4 510(k) clearances
Titan Implants, Inc. is registered with the FDA (registration 2249649) in Bergenfield, NJ, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 23, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2249649
- FEI number
- 3003024548
- Address
- 18 Columbia Ave., Bergenfield, NJ, United States, 07621
- Owner or operator
- TITAN IMPLANTS, INC. (9041410)
- Roles
- Manufacturer
- First device listed
- May 19, 2000
- Registered through
- 2026
- Brand names listed
- TITAN IMPLANTS, TITAN IMPLANTS, INC., Titan Implants
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| March 23, 2005 | K042715 | TITAN DENTAL IMPLANT ATTACHMENT | NHA | Substantially Equivalent | Titan Implants, Inc. | accessdata.fda.gov |
| January 14, 2005 | K042971 | TITAN DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Titan Implants, Inc. | accessdata.fda.gov |
| March 4, 2002 | K001638 | O-RING PROSTHETIC ATTACHMENT | DZE | Substantially Equivalent | Titan Implants | accessdata.fda.gov |
| July 5, 2001 | K003818 | TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS | DZE | Substantially Equivalent | Titan Implants | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated March 23, 2005. 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.