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Straumann Dental Implant System

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
STRAUMANN DENTAL IMPLANT SYSTEM FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Standard Plus Implant D 4.1mm RN SLActive® 10mm, Ti FDA UDI
Model / Reference
SLActive Titanium TL FDA UDI
Description
Standard Plus Implant D 4.1mm RN SLActive® 10mm, Ti FDA UDI

Identifiers

Catalog Number
033.052S FDA UDI
Primary DI / UDI-DI
07630031714695 FDA UDI
510(k) Number
K033984 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 — 10 Millimeter FDA UDI
Outer Diameter — 4.1 Millimeter FDA UDI

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

Cleared under the same submission

K033984 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 8f2db315-6f30-4058-ac50-c40385f40030 39 fields · synced May 31, 2026