Manufacturer registered with FDA
Kelsey Dental LLC
The Woodlands, TX, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Kelsey Dental LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | medical titanium materials | 2025 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | arylic dentures; E.max crown/bridge; metal framework dentures; Porcelain fused to metal crown/bridges; Valplast; zirconi | 2025 |
| Preformed CrownELZ · Class 1 | — | Lister | Prefabricated Crown | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | STRAUMANN DENTAL IMPLANT SYSTEM | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Kelsey Dental LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Institut Straumann AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Aug 2003 | K032498 | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KELSEY DENTAL LLCFDA reg. 3039641923 | The Woodlands, TX, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093877). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.