FDA.report

Geo ArcB Scanbody

Primary DI
08800028739942
Brand
Geo ArcB Scanbody
Company
GEOMEDI INC.
Model
ArcB-5017N
Device description
Geo Scanbody is a dental implant surgical instrument used for digital impression acquisition to create an oral reproduction model after implant fixture placement. It has a cross-sectional shape for directional and positional indication, and is connected to the fixture by a screw-retained method.
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800028739942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800028739942088000287399428800028739942

GMDN Terms

TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694173762
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08800028739935Geo ArcB ScanbodyArcB-3025N2025-12-30
08800028739911Geo ArcB ScanbodyArcB-3017N2025-12-23
08800028739928Geo ArcB ScanbodyArcB-3021N2025-12-23
08800028739959Geo ArcB ScanbodyArcB-5021N2025-12-23
08800028739966Geo ArcB ScanbodyArcB-5025N2025-12-23
08800028739973Geo Impression Direct CopingIPDC-5055N2025-12-23
08800028739980Geo Impression Direct CopingIPDC-5070N2025-12-23
08800028739997Geo ArcB Scanbody AnalogIMP-ArcB2025-12-23
08800028740009Geo Screw DriverSRDNBS2025-12-23
08800028740016Geo Screw DriverSRDNBR2025-12-23
08800028740023Geo Screw DriverSRDNBL2025-12-23
08800028740030Geo Screw DriverSLDNBS2025-12-23
08800028740047Geo Impression Direct CopingIPDC-5040N2025-12-23
08800028740054Geo ArcB Scanbody KitABSK-SET-B2025-12-23
08800028740061Geo ScrewArcB30NC2025-12-23
08800028740078Geo ScrewArcB30NC52025-12-23
08800028740085Geo ScrewArcB50NC2025-12-23
08800028740092Geo ScrewArcB50NC52025-12-23
08800028739898Geo ArcB Scanbody KitABSK-SET-A2025-12-18
08800028711290Geo ScanbodyGMS-DERL2025-07-10

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