Home GUDID 08800342274280 OneArch Scan Body
Primary DI 08800342274280
Brand OneArch Scan Body
Company Osstem Implant Co., Ltd.
Model OASB01MU
Published 2026-03-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800342274280 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800342274280 08800342274280 8800342274280
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, temporary, preformed, single-use A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 689051793 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08800342290136 OneArch Scan Body KIT HOASBK 2026-04-02 08800342293830 OneArch Scan Body HOASB01MU 2026-04-02 08800342293847 OneArch Scan Body HOASB02MU 2026-04-02 08800342293854 OneArch Scan Body HOASB03MU 2026-04-02 08800342293861 OneArch Scan Body HOASB04MU 2026-04-02 08800342293878 OneArch Scan Body HOASB05MU 2026-04-02 08800342293885 OneArch Scan Body HOASB06MU 2026-04-02 08800000987293 Bone Screw, Bone Tack BSCH1404 2026-03-09 08800000987309 Bone Screw, Bone Tack BSCH1406 2026-03-09 08800000987316 Bone Screw, Bone Tack BSCH1408 2026-03-09 08800000987323 Bone Screw, Bone Tack BSCH2008 2026-03-09 08800000987330 Bone Screw, Bone Tack BSCH2010 2026-03-09 08800000987347 Bone Screw, Bone Tack BSCH2012 2026-03-09 08800000987354 Bone Screw, Bone Tack BSCH2014 2026-03-09 08800000987361 Bone Screw, Bone Tack BSCH2016 2026-03-09 08800040644095 Bone Screw BSCH1203 2026-03-09 08800040644118 Bone Screw BSCH1204 2026-03-09 08800040644132 Bone Screw BSCH1205 2026-03-09 08800040654599 Bone Screw, Bone Tack OBT3 2026-03-09 08800040655848 OssBuilder System SBS2008I 2026-03-09
Other Devices Sharing Product Codes#