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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
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
EO Gold cap 15°, Ø 4.8mm, L 5.5mm, ceramicon FDA UDI
Model / Reference
EO FDA UDI
Description
EO Gold cap 15°, Ø 4.8mm, L 5.5mm, ceramicon FDA UDI

Identifiers

Catalog Number
048.236 FDA UDI
Primary DI / UDI-DI
07630031723703 FDA UDI
FDA Product Code
KCZ FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 15 degree FDA UDI
Length — 5.5 Millimeter FDA UDI
Outer Diameter — 4.8 Millimeter FDA UDI

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

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 68553bb3-51da-4c4a-ab0f-88f9d8ab18b7 37 fields · synced May 30, 2026