Identity
- Trade Name
- Tilite Ceramic Alloys - Premium FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- 100 grams of Tilite (Premium) FDA UDI
- Model / Reference
- 120 FDA UDI
- Description
- 100 grams of Tilite (Premium) FDA UDI
Identifiers
- Catalog Number
- 120 FDA UDI
- Primary DI / UDI-DI
- D791200 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 - Premium by Talladium, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting non-noble alloy.
- Micronium Exclusiv, sample — Schütz Dental GmbH · Class II
- EC 610 — Cookson Precious Metals Ltd · Class IIa
- TICONIUM — CMP INDUSTRIES LLC · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- NOBILIUM — CMP INDUSTRIES LLC · Class II
- System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
- Magnum Solare — Mesa Italia S.r.l. · Class IIa
- NIRANIUM — CMP INDUSTRIES LLC · Class II
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 - Gamma Matt — 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 - 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Talladium, Inc.
Sources (1)
- FDA UDI 4c82004e-ec0b-4328-a898-7b2d4c9d5b37 35 fields · synced Jun 1, 2026