Identity
- Trade Name
- CROSS LINKED 2 FDA UDI
- Generic Name
- Partial denture FDA UDI
- Device Name
- Resin Artificial Teeth FDA UDI
- Model / Reference
- CL.T2ZA9 FDA UDI
- Description
- Resin Artificial Teeth FDA UDI
Identifiers
- Catalog Number
- CL.T2ZA9 FDA UDI
- Primary DI / UDI-DI
- EPOLCLT2ZA9 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Partial denture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Meter FDA UDI
The CROSS LINKED 2 is a custom-made, resin artificial teeth device designed for partial denture replacement in adults. It offers unparalleled stability and comfort, making it an ideal solution for patients seeking to enhance the appearance and function of their natural teeth.
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
- POLIDENT d.o.o.
Sources (1)
- FDA UDI 677316ed-f962-49c5-9626-f75773e6c47c 38 fields · synced Jul 21, 2026