Identity
- Trade Name
- Luminesse HF Gingivals FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- 1961DP FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7911961DP0 FDA UDI
- 510(k) Number
- K140848 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
Luminesse HF Gingivals by Talladium, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Cleared under the same submission
K140848 also covers:
- Luminesse HF Dentin Modifiers — TALLADIUM, INC.
- Luminesse HF Dentin Powder — TALLADIUM, INC.
- Luminesse HF Dentin Powder — TALLADIUM, INC.
- Luminesse HF Dentin Powder — TALLADIUM, INC.
- Luminesse HF Incisal Trans — TALLADIUM, INC.
- Luminesse HF Incisal Trans — TALLADIUM, INC.
- Luminesse HF Incisal Trans — TALLADIUM, INC.
- Luminesse HF Margin — TALLADIUM, INC.
- Luminesse HF Margin — TALLADIUM, INC.
- Luminesse HF Neck Trans — TALLADIUM, INC.
- Luminesse HF Opacious Dentins — TALLADIUM, INC.
- Luminesse HF Opacious Dentins — TALLADIUM, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Talladium, Inc.
Sources (1)
- FDA UDI f99e21b3-f0a4-4edc-941c-5e5e83977ad5 33 fields · synced Jun 1, 2026