FDA.report

Geo Screw

Primary DI
08800028734138
Brand
Geo Screw
Company
GEOMEDI INC.
Model
AC-SUM
Device description
Geo Screw is used to connect the abutment to the fixture.
Published
2025-06-27
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions

SubmissionSupplement
K242978000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242978000Geo AbutmentGeomedi Co,., Ltd.2025-06-16NHA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800028734138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800028734138088000287341388800028734138

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. 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
false
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
08800028739942Geo ArcB ScanbodyArcB-5017N2025-12-30
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

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07290120482678IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486720NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486973RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487024RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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