Identity
- Trade Name
- Luminesse Universal Stain Shades FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- 1906OL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7911906OL0 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 Universal Stain Shades by Talladium, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, ceramic.
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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 Gingivals — 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.
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 |
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Manufacturer
- Manufacturer
- Talladium, Inc.
Sources (1)
- FDA UDI 6ff717cf-a265-42bb-b24c-fefd6bf86ca0 33 fields · synced Jun 8, 2026