FDA.report

Scan Bar

Primary DI
08809977450694
Brand
Scan Bar
Company
Megagen Implant Co. Ltd
Model
AXSB406
Catalog number
AXSB406T
Published
2024-07-10
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
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809977450694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809977450694088099774506948809977450694

GMDN Terms

TermDefinition
Dental implant abutment trialA copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687388178
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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 DIBrandModelCatalogPublished
08800352213811Fixture DriverARFDUARFDU2026-05-26
08800352213828Fixture DriverARFDSARFDS2026-05-26
08800352213835Fixture DriverARFDLARFDL2026-05-26
08809854028510Duo Surgical KitMKBDAO3000LMKBDAO3000L2023-11-10
08809854028527Duo Surgical KitMKBDST3000LMKBDST3000L2023-11-10
08809985659300R2GATE WindowsR2GATE2026-03-24
08800292999219Hand DriverASCHDT615ASCHDT6152026-03-20
08800292999226Hand DriverASCHDT620ASCHDT6202026-03-20
08800292999233Hand DriverASCHDT625ASCHDT6252026-03-20
08800292999240Hand DriverASCHDT630ASCHDT6302026-03-20
08800292999257Removal ScrewARATGRS20ARATGRS202026-03-20
08800292999264Screw DriverASCSD15ASCSD152026-03-20
08800292999271Screw DriverASCSD20ASCSD202026-03-20
08800292999288Screw DriverASCSD25ASCSD252026-03-20
08800292999295Screw DriverASCSD30ASCSD302026-03-20
08806388221981Intermezzo FixtureIMTI2513IMTI25132015-06-25
08806388221998Intermezzo FixtureIMTI2515IMTI25152015-06-25
08806388222025Intermezzo FixtureIMTI3110IMTI31102015-06-25
08806388222049Intermezzo FixtureIMTI3113IMTI31132015-06-25
08806388221875Intermezzo FixtureIMTI1615IMTI16152015-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26