Data / Medical devices / United States / American Dental Implant Corporation
American Dental Implant Corporation: FDA-registered device maker in New Castle, PA, United States, 4 510(k) clearances
American Dental Implant Corporation is registered with the FDA (registration 2523430) in New Castle, PA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 6, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2523430
- FEI number
- 3004595327
- Address
- 2415 Wilmington RD., New Castle, PA, United States, 16105
- Owner or operator
- AMERICAN DENTAL IMPLANT CORPORATION (9061617)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- October 15, 2007
- Registered through
- 2027
- Brand names listed
- ADI Abutment, ADI Bone Drill, American Dental Implant, Dental Accessories for American Dental Implant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| May 6, 2008 | K080397 | AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM | NHA | Substantially Equivalent | American Dental Implant Corporation | accessdata.fda.gov |
| September 21, 2004 | K042462 | AMERICAN DENTAL IMPLANT | DZE | Substantially Equivalent | American Dental Implant Corporation | accessdata.fda.gov |
| July 14, 1995 | K945706 | BONE DRILL | DZE | Substantially Equivalent | Osteo Implant Corp. | accessdata.fda.gov |
| February 10, 1987 | K862854 | OSTEO TITANIUM DENTAL IMPLANT | DZE | Substantially Equivalent | Osteo Implant Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated May 6, 2008. 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.