FDA.report

US Implant Pick-up Impression Coping

Primary DI
08809892357672
Brand
US Implant Pick-up Impression Coping
Company
Osstem Implant Co., Ltd.
Model
ICFR600
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
08809892357672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809892357672088098923576728809892357672

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
689051793
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
08800000987293Bone Screw, Bone TackBSCH14042026-03-09
08800000987309Bone Screw, Bone TackBSCH14062026-03-09
08800000987316Bone Screw, Bone TackBSCH14082026-03-09
08800000987323Bone Screw, Bone TackBSCH20082026-03-09
08800000987330Bone Screw, Bone TackBSCH20102026-03-09
08800000987347Bone Screw, Bone TackBSCH20122026-03-09
08800000987354Bone Screw, Bone TackBSCH20142026-03-09
08800000987361Bone Screw, Bone TackBSCH20162026-03-09
08800040644095Bone ScrewBSCH12032026-03-09
08800040644118Bone ScrewBSCH12042026-03-09
08800040644132Bone ScrewBSCH12052026-03-09
08800040654599Bone Screw, Bone TackOBT32026-03-09
08800040655848OssBuilder SystemSBS2008I2026-03-09
08800040655862OssBuilder SystemSBS2010I2026-03-09
08800040655886OssBuilder SystemSBS2011I2026-03-09
08800040655909OssBuilder SystemSBS2013I2026-03-09
08809892366858SS Abutment SystemSSCAP4814CTH2026-03-09
08809892366896SS Abutment SystemSSCAP4824CTH2026-03-09
08809892366957SS Abutment SystemSSCAP4826ENTH2026-03-09
08809892366964SS Abutment SystemSSCAP4826ETH2026-03-09

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