FDA.report

Transfer Impression Coping

Primary DI
08800011263744
Brand
Transfer Impression Coping
Company
Point Nix Co., Ltd.
Model
OSICT5011H
Published
2022-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800011263744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800011263744088000112637448800011263744

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screw analog, reusableA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
695333960
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
08800011264758Torque wrenchTW2022-03-03
08800011260019Drill ExtensionPDE23002022-02-21
08800011260026Fixture PinPIFP35002022-02-21
08800011260033Fixture PinPSFP33002022-02-21
08800011260040OsteotomeOST282022-02-21
08800011260057OsteotomeOST332022-02-21
08800011260064OsteotomeOST372022-02-21
08800011260071OsteotomeOST422022-02-21
08800011260088OsteotomeOSTM2022-02-21
08800011260095Guide pinOSICTS2022-02-21
08800011260101Guide pinOSICTL2022-02-21
08800011260118Guide pinOSICTE2022-02-21
08800011260125Guide pinOSICTMS2022-02-21
08800011260132Guide pinOSICTML2022-02-21
08800011260149Guide pinOSICTME2022-02-21
08800011260170Guide pinOSICPMS2022-02-21
08800011260187Guide pinOSICPME2022-02-21
08800011260194Guide pinOSICPML2022-02-21
08800011260217Guide pinOSICPL2022-02-21
08800011260224Guide pinOSICPE2022-02-21

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
08800076410008Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410015Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410022Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410039Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410046Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410053Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076414440AOT Digital AnalogTruabutment Korea Co.,LtdNDP2026-03-24
08800076414662Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076414679Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076418073Drill ExtensionTruabutment Korea Co.,LtdNDP2026-03-24
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