Straumann Extraoral Implant System

FDA UDI

Class I (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: Straumann Extraoral Implant System FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: EO implant Ø 3.3 / 5.5 mm, Insertion depth 2.5 mm, Titanium FDA UDI
Model / Reference: EO FDA UDI
Description: EO implant Ø 3.3 / 5.5 mm, Insertion depth 2.5 mm, Titanium FDA UDI

Identifiers

Catalog Number: 042.365S FDA UDI
Primary DI / UDI-DI: 07630031718204 FDA UDI
FDA Product Code: KCZ FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.3800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 5.5 Millimeter FDA UDI
Outer Diameter — 3.3 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Straumann Extraoral Implant System by Institut Straumann SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Institut Straumann SA

Sources (1)

FDA UDI 575568dd-e1ae-4123-a358-1d7e6050c722 37 fields · synced May 30, 2026