Base metal alloy

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: Base metal alloy FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: coron CoCr 10 units bridge framework FDA UDI
Model / Reference: Bridges (tooth borne) FDA UDI
Description: coron CoCr 10 units bridge framework FDA UDI

Identifiers

Catalog Number: 010.1010 FDA UDI
Primary DI / UDI-DI: 07630031701763 FDA UDI
FDA Product Code: EJH FDA UDI
GMDN Term: Dental bridge, metal-ceramic 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental bridge, metal-ceramic

Base metal alloy by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TITANIT 5 95H18 — Zirkonzahn GmbH · Class II

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: Institut Straumann SA

Sources (1)

FDA UDI 9ea74f6f-9240-48d1-82d0-286183edaf34 35 fields · synced Jun 1, 2026