OneArch Scan Body

GUDID 08800342274389

Osstem Implant Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08800342274389
NIH Device Record Keyf2369132-7ef1-4235-b165-2c1361f63179
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneArch Scan Body
Version Model NumberOASB06MU
Company DUNS689051793
Company NameOsstem Implant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800342274389 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


[08800342274389]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-13
Device Publish Date2026-03-05

On-Brand Devices [OneArch Scan Body]

08800342274389OASB06MU
08800342274365OASB05MU
08800342274341OASB04MU
08800342274327OASB03MU
08800342274303OASB02MU
08800342274280OASB01MU

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