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Modification To:straumann Guided Instruments

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Standard Implant D 4.1mm, RN, SLActive® 12mm, Ti guided FDA UDI
Model / Reference
SLActive Titanium TL FDA UDI
Description
Standard Implant D 4.1mm, RN, SLActive® 12mm, Ti guided FDA UDI

Identifiers

Catalog Number
033.033G FDA UDI
Primary DI / UDI-DI
07630031714558 FDA UDI
510(k) Number
K090260 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 12 Millimeter FDA UDI
Outer Diameter — 4.1 Millimeter FDA UDI

Modification To:straumann Guided Instruments by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K090260 also covers:

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 5211dfc5-74e8-41c8-bfd1-793cd0f339ae 39 fields · synced May 31, 2026