FDA.reportPublic FDA data

OneArch KIT

Primary DI
08800342307186
Brand
OneArch KIT
Company
Osstem Implant Co., Ltd.
Model
OOARK
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NYEFixture Mount Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYEFixture Mount KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800342307186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800342307186088003423071868800342307186

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689051793
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800342307193OneArch KITHOARK2026-10-07
08809917132710Healing Abutment SystemTSHAL4510M2026-07-29
08800342290136OneArch Scan Body KITHOASBK2026-04-02
08800342293830OneArch Scan BodyHOASB01MU2026-04-02
08800342293847OneArch Scan BodyHOASB02MU2026-04-02
08800342293854OneArch Scan BodyHOASB03MU2026-04-02
08800342293861OneArch Scan BodyHOASB04MU2026-04-02
08800342293878OneArch Scan BodyHOASB05MU2026-04-02
08800342293885OneArch Scan BodyHOASB06MU2026-04-02
08800000987293Bone Screw, Bone TackBSCH14042026-03-09
08800000987309Bone Screw, Bone TackBSCH14062026-03-09
08800000987316Bone Screw, Bone TackBSCH14082026-03-09
08800000987323Bone Screw, Bone TackBSCH20082026-03-09
08800000987330Bone Screw, Bone TackBSCH20102026-03-09
08800000987347Bone Screw, Bone TackBSCH20122026-03-09
08800000987354Bone Screw, Bone TackBSCH20142026-03-09
08800000987361Bone Screw, Bone TackBSCH20162026-03-09
08800040644095Bone ScrewBSCH12032026-03-09
08800040644118Bone ScrewBSCH12042026-03-09
08800040644132Bone ScrewBSCH12052026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800342307193OneArch KITOsstem Implant Co., Ltd.NYE2026-10-07
06947600330943BLT Guided KitBIO CONCEPT Co., Ltd.NYE2026-05-27
08800342290136OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-04-02
08800342289710OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-03-05
008500733335703DDX Tapered Drill Kit 3D DIAGNOSTIX, INC.NYE2025-09-10
008500733335633DDX Straight Drill Kit3D DIAGNOSTIX, INC.NYE2025-09-10
08800271260286122 TAPER FULL KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260293122 TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260309485 KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260316TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
06947600302094TL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304388BL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304395BLT MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304654BC Removal Kit,BCJJ-SBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304661BC Removal Kit,BCJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316350BV Removal Kit,BVJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316589BV MINI KitBIO CONCEPT Co., Ltd.NYE2025-03-25
08800271240516Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271241544Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271234409OneArch KITOsstem Implant Co., Ltd.NYE2025-01-03
08800271229733485 KITOsstem Implant Co., Ltd.NYE2024-12-10
08800271233976OneArch KITOsstem Implant Co., Ltd.NYE2024-12-09
06947600319948BV Standard KlTBIO CONCEPT Co., Ltd.NYE2024-11-27
08800271219987Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
08800271219994Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
06947600316596BV Guided Kit,BVBIO CONCEPT Co., Ltd.NYE2024-09-18
08800271225438SIMPLE KITOsstem Implant Co., Ltd.NYE2024-09-10
08800271218409Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08800271218416Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070012122 Taper Full KITOsstem Implant Co., Ltd.NYE2024-08-20