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Abutment And Prosthetic Accessories To The Iti Dental Implant System

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
RN synOcta® 1.5 screw-retained Abutment, H 1.5mm, Ti FDA UDI
Model / Reference
Final Abutments FDA UDI
Description
RN synOcta® 1.5 screw-retained Abutment, H 1.5mm, Ti FDA UDI

Identifiers

Catalog Number
048.602 FDA UDI
Primary DI / UDI-DI
07630031725202 FDA UDI
510(k) Number
K022859 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Abutment And Prosthetic Accessories To The Iti Dental Implant System by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K022859 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 b01b96e9-43fb-44b4-a447-31dcb6a8bad8 38 fields · synced Jun 8, 2026