Identity
- Trade Name
- Tilite Ceramic Alloys - Gamma Matt FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Model / Reference
- 136 FDA UDI
Identifiers
- Catalog Number
- 136 FDA UDI
- Primary DI / UDI-DI
- D7911360 FDA UDI
- 510(k) Number
- K894085 FDA UDI
- FDA Product Code
- EJH FDA UDI
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3710 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental casting non-noble alloy
Tilite Ceramic Alloys - Gamma Matt by Talladium, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K894085 also covers:
- Tilite Ceramic Alloys - "O" — TALLADIUM, INC.
- Tilite Ceramic Alloys - "S" — TALLADIUM, INC.
- Tilite Ceramic Alloys - "V" — TALLADIUM, INC.
- Tilite Ceramic Alloys - Omega — TALLADIUM, INC.
- Tilite Ceramic Alloys - Omega — TALLADIUM, INC.
- Tilite Ceramic Alloys - Premium — TALLADIUM, INC.
- Tilite Ceramic Alloys - Premium — TALLADIUM, INC.
- Tilite Ceramic Alloys - Premium — TALLADIUM, INC.
- Tilite Ceramic Alloys - Star — TALLADIUM, INC.
- Tilite Ceramic Alloys - Star — TALLADIUM, INC.
- Tilite Ceramic Alloys - V — TALLADIUM, INC.
- Tilite Ceramic Alloys - Vita — 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 5ee94d55-6eca-448d-8717-f6c1b6ea88db 34 fields · synced Jun 8, 2026