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KATANA Zirconia

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
KATANA Zirconia FDA UDI
Generic Name
Custom-made dental crown, ceramic FDA UDI
Device Name
zerion® HTML single unit , xSHADEx FDA UDI
Model / Reference
Crowns FDA UDI
Description
zerion® HTML single unit , xSHADEx FDA UDI

Identifiers

Catalog Number
010.0109 FDA UDI
Primary DI / UDI-DI
07630031753373 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
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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Custom-made dental crown, ceramic

KATANA Zirconia by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made dental crown, ceramic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann SA

Sources (1)

  • FDA UDI 67ffe829-2576-4685-b20e-d73df012e679 35 fields · synced Jun 1, 2026