FDA Registration
Active
🇺🇸 United States
UPCERA DENTAL AMERICA INC.
Reg #: 3019596325
·
FEI: 3019596325
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- UPCERA DENTAL AMERICA INC.
- Registration Number
- 3019596325
- FEI Number
- 3019596325
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13100 Alondra Blvd. Ste. 105
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141724
Owner / Operator
- Firm Name
- Upcera Dental America Inc.
- Operator Number
- 10082186
- Address
- 13100 Alondra Blvd. Ste. 105
- City
- Cerritos
- State
- CA
- Postal Code
- 90703
- Country
- US
- Correspondent
- Kevin Arakelyan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2021-12-25 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-09-25 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2022-12-29 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2021-12-25 |
Proprietary Names
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series)
Glaze Paste, Glaze Powder, and Glaze Liquid
Upcera Coloring Liquid (I and II)
Wax Block
Hyramic CAD/CAM Restorative
POWDER, PORCELAIN
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198