FDA.reportPublic FDA data

Transfer Impression Coping

Primary DI
08800070218068
Brand
Transfer Impression Coping
Company
Izenimplant Co., Ltd.
Model
TISRH65LS
Published
2022-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08800070218068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070218068088000702180688800070218068

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screw analog, single-useA 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. Some types are referred to as a guide pin, and may 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694625347
Device count
1
Premarket exempt
true
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
08800070203156ZENEX MULTI FixtureZMRW70132026-06-04
08800070203217ZENEX MULTI FixtureZMRW50132026-06-04
08800070203224ZENEX MULTI FixtureZMRW50062026-06-04
08800070203231ZENEX MULTI FixtureZMRW50152026-06-04
08800070203248ZENEX MULTI FixtureZMRW55072026-06-04
08800070203255ZENEX MULTI FixtureZMRW55082026-06-04
08800070203262ZENEX MULTI FixtureZMRW55102026-06-04
08800070203279ZENEX MULTI FixtureZMRW55112026-06-04
08800070203286ZENEX MULTI FixtureZMRW55132026-06-04
08800070203293ZENEX MULTI FixtureZMRW55062026-06-04
08800070203309ZENEX MULTI FixtureZMRW55152026-06-04
08800070203316ZENEX MULTI FixtureZMRW60072026-06-04
08800070203323ZENEX MULTI FixtureZMRW60082026-06-04
08800070203330ZENEX MULTI FixtureZMRW60102026-06-04
08800070203347ZENEX MULTI FixtureZMRW60112026-06-04
08800070203354ZENEX MULTI FixtureZMRW60062026-06-04
08800070203361ZENEX MULTI FixtureZMRW60132026-06-04
08800070203378ZENEX MULTI FixtureZMRW70072026-06-04
08800070203385ZENEX MULTI FixtureZMRW70082026-06-04
08800070203392ZENEX MULTI FixtureZMRW70102026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03
07630031778475NAInstitut Straumann AGNDP2026-06-03