FDA Registration
Active
🇺🇸 United States
KELSEY DENTAL LLC
Reg #: 3039641923
·
FEI: 3039641923
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- KELSEY DENTAL LLC
- Registration Number
- 3039641923
- FEI Number
- 3039641923
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 32222 Tamina Rd Ste 5-09a
- City
- The Woodlands
- State
- TX
- ZIP
- 77354
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032498
Owner / Operator
- Firm Name
- Kelsey Dental LLC
- Operator Number
- 10093877
- Address
- 32222 Tamina Road, STE A5-09
- City
- The Woodlands
- State
- TX
- Postal Code
- 77354
- Country
- US
- Correspondent
- Darren Kelsey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2025-12-03 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2025-08-06 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2025-08-10 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-07-26 |
| Dentures, Full | NSL | Class N | Unknown | No | 2025-12-03 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2025-12-03 |
| Denture Preformed (Partially Prefabricated Denture) | EKO | Class 2 | Dental | No | 2025-07-29 |
Proprietary Names
Zirconia Teeth and Glaze
arylic dentures; E.max crown/bridge; metal framework dentures; Porcelain fused to metal crown/bridges; Valplast; zirconi
Prefabricated Crown
STRAUMANN DENTAL IMPLANT SYSTEM
Denture Material and Adhesive
Titanium Bar
medical titanium materials
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198