FDA.reportPublic FDA data

Geo Screw

Primary DI
08800028733612
Brand
Geo Screw
Company
GEOMEDI INC.
Model
AC-MARR
Device description
Geo Screw is used to connect the abutment to the fixture.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242978000Geo AbutmentGeomedi Co,., Ltd.2025-06-16NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800028733612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800028733612088000287336128800028733612

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694173762
Device count
1
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
08800028740320Geo ArcB ScanbodyArcB-3017N-22026-06-25
08800028740337Geo ArcB ScanbodyArcB-3021N-22026-06-25
08800028740344Geo ArcB ScanbodyArcB-3025N-22026-06-25
08800028740351Geo Impression Direct CopingIPDC-5070MN2026-06-25
08800028740450Geo ArcB Scanbody KitABSK-SET-C2026-06-25
08800028740467Geo ArcB Scanbody KitABSK-SET-D2026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
06009544052036N/ASOUTHERN IMPLANTS (PTY) LTDNHA2026-09-30
00840481138492LOCATOR, compatible with Nobel BiocareZest Anchors, LLCNHA2026-09-29
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29