FDA.report

Geo Impression Direct Coping

Primary DI
08800028739980
Brand
Geo Impression Direct Coping
Company
GEOMEDI INC.
Model
IPDC-5070N
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
2025-12-23
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
08800028739980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800028739980088000287399808800028739980

GMDN Terms

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
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
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
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800076409989Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076409996Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
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08800076410022Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
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08800076410046Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
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08800076423664URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423671URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423718URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423725URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24