Data / Medical devices / United States / Head Dental Corporation
Head Dental Corporation: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Head Dental Corporation is registered with the FDA (registration 2087470) in Irvine, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 20, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2087470
- FEI number
- 3003904663
- Address
- 17972 Sky Park Circle Suite J, Irvine, CA, United States, 92614
- Owner or operator
- HEAD DENTAL CORP. (9051690)
- Roles
- Repackager or relabeler
- First device listed
- December 1, 2023
- Registered through
- 2026
- Brand names listed
- Handpiece, air-powered, dental, ORTHODONTIC PLIERS, PLIERS, ORTHODONTIC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Articulators | EJP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | 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 |
|---|---|---|---|---|---|---|
| March 20, 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | EFB | Substantially Equivalent | Nakamura Magnifier Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Articulators
- All makers of Plier, Orthodontic
Updated March 20, 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.