FDA.reportPublic FDA data

Anchor Screw,Φ1.8mm,L22.3mm

Primary DI
06947600319627
Brand
Anchor Screw,Φ1.8mm,L22.3mm
Company
BIO CONCEPT Co., Ltd.
Model
353290
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947600319627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947600319627069476003196276947600319627

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation drilling template retention pinA small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). 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
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
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09