Data / Medical devices / United States / Kelsey Dental LLC
Kelsey Dental LLC: FDA-registered device maker in The Woodlands, TX, United States, 1 510(k) clearance
Kelsey Dental LLC is registered with the FDA (registration 3039641923) in The Woodlands, TX, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039641923
- Address
- 32222 Tamina Rd Ste 5-09a, The Woodlands, TX, United States, 77354
- Owner or operator
- Kelsey Dental LLC (10093877)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 26, 2025
- Registered through
- 2026
- Brand names listed
- Denture Material and Adhesive, Prefabricated Crown, STRAUMANN DENTAL IMPLANT SYSTEM, Titanium Bar, Zirconia Teeth and Glaze, arylic dentures; E.max crown/bridge; metal framework dentures; Porcelain fused to metal crown/bridges; Valplast; zirconi, medical titanium materials
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Specification developer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Complaint file establishment | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Specification developer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Specification developer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 27, 2003 | K032498 | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) | NHA | Substantially Equivalent | Straumann USA | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Base Metal
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Porcelain
- All makers of Teeth, Artificial, Posterior With Metal Insert
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Crown, Preformed
Updated August 27, 2003. 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.