FDA.reportPublic FDA data

Geo Impression Direct Coping

Primary DI
08800028740351
Brand
Geo Impression Direct Coping
Company
GEOMEDI INC.
Model
IPDC-5070MN
Device description
The device is an auxiliary instrument used during digital impression procedures to accurately scan intraoral soft tissue morphology. It is connected to the dental implant superstructure for impression taking and fabrication of prosthetic restorations and oral replica models.
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
08800028740351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800028740351088000287403518800028740351

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
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 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
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
08800028715700Geo Multibase AbutmentLL2-3ICW-H22026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14