FDA.reportPublic FDA data

Geo ArcB Scanbody

Primary DI
08800028739911
Brand
Geo ArcB Scanbody
Company
GEOMEDI INC.
Model
ArcB-3017N
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
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
08800028739911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800028739911088000287399118800028739911

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694173762
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
08800028713126Geo CMFit AbutmentCMFit10-3ICM-H22026-05-06
08800028713133Geo CMFit AbutmentCMFit14-3ICM-H22026-05-06
08800028713140Geo CMFit AbutmentCMFit10-3ICR-H22026-05-06
08800028713157Geo CMFit AbutmentCMFit14-3ICR-H22026-05-06
08800028713881Geo CMFit AbutmentCMFit10-3IC60-H22026-05-06
08800028713898Geo CMFit AbutmentCMFit10-3ICW-H22026-05-06
08800028714475Geo CMFit AbutmentCMFit14-3IC60-H22026-05-06
08800028714482Geo CMFit AbutmentCMFit14-3ICW-H22026-05-06
08800028715649Geo Multibase AbutmentLL2-3ICM-H22026-05-06
08800028715656Geo Multibase AbutmentLL2-3ICM-N22026-05-06
08800028715663Geo Multibase AbutmentLL2-3ICR-H22026-05-06
08800028715670Geo Multibase AbutmentLL2-3ICR-N22026-05-06
08800028715687Geo Multibase AbutmentLL2-3IC60-H22026-05-06
08800028715694Geo Multibase AbutmentLL2-3IC60-N22026-05-06
08800028715700Geo Multibase AbutmentLL2-3ICW-H22026-05-06
08800028715717Geo Multibase AbutmentLL2-3ICW-N22026-05-06
08800028734732Geo Multibase AbutmentLL2-KEP35-T22026-05-06
08800028734749Geo Multibase AbutmentLL2-KEP35-N22026-05-06
08800028734756Geo Multibase AbutmentLL2-KEP41-T22026-05-06
08800028734763Geo Multibase AbutmentLL2-KEP41-N22026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435673516664DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-03
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03