Identity
- Trade Name
- KATANA Zirconia FDA UDI
- Generic Name
- Custom-made dental crown, ceramic FDA UDI
- Device Name
- zerion® ML single-unit restoration FDA UDI
- Model / Reference
- Crowns FDA UDI
- Description
- zerion® ML single-unit restoration FDA UDI
Identifiers
- Catalog Number
- 010.0051 FDA UDI
- Primary DI / UDI-DI
- 07630031731098 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Custom-made dental crown, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
KATANA Zirconia by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Institut Straumann SA
Sources (1)
- FDA UDI 84171bee-e19f-4a34-bc6a-86f56a20b0f9 36 fields · synced Jun 6, 2026