Identity
- Trade Name
- System KN FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Nickel based dental casting bonding alloy, type 3 FDA UDI
- Model / Reference
- 2005001 FDA UDI
- Description
- Nickel based dental casting bonding alloy, type 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EADT20050011 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
Yes
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
Yes
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
System KN by Adentatec GmbH Competence in Dental — 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
- Magnum Solare — Mesa Italia S.r.l. · Class IIa
- NIRANIUM — CMP INDUSTRIES LLC · Class II
- Matticraft 75+ — Cookson Precious Metals Ltd · Class IIa
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
- Adentatec GmbH Competence in Dental
Sources (1)
- FDA UDI 812c23c6-4cd2-4c52-b407-da5d597374d5 33 fields · synced May 31, 2026