FDA.reportPublic FDA data

BV Guided Kit,BV

Primary DI
06947600316596
Brand
BV Guided Kit,BV
Company
BIO CONCEPT Co., Ltd.
Model
357300
Published
2024-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06947600316596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947600316596069476003165966947600316596

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
527603266
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,Guided1595902026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,Guided1596002026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,Guided1596102026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,Guided1596202026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,Guided1596302026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,Guided1596402026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,Guided1596502026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,Guided1596602026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,Guided1596702026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,Guided1596802026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,Guided1596902026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,Guided1597002026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,Guided1597102026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,Guided1597202026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,Guided1597302026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,Guided1597402026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,Guided1597502026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,Guided1597602026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,Guided1597702026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,Guided1597802026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08809917070029122 Taper KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070036123 Straight KITOsstem Implant Co., Ltd.NYE2024-08-20