FDA.reportPublic FDA data

Temporary Cylinder

Primary DI
08800362105144
Brand
Temporary Cylinder
Company
DIMPLO Ltd.
Model
MUATMC23
Catalog number
MUATMC23
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251605000DIMPLO Implant SystemDIMPLO, Ltd.2025-12-22DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800362105144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800362105144088003621051448800362105144

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
963392194
Device count
1
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
08800362104925Temporary Cylinder ScrewMUATW120MUATW1202026-04-07
08800362104932Temporary Cylinder ScrewMUATW123MUATW1232026-04-07
08800362104949Temporary Cylinder ScrewMUATW127MUATW1272026-04-07
08800362104956Temporary Cylinder ScrewMUATWTOXMUATWTOX2026-04-07
08800362104963Temporary Cylinder ScrewMUATWUNIMUATWUNI2026-04-07
08800362104970Temporary Cylinder ScrewMUATW120PMUATW120P2026-04-07
08800362104987Temporary Cylinder ScrewMUATW123PMUATW123P2026-04-07
08800362104994Temporary Cylinder ScrewMUATW127PMUATW127P2026-04-07
08800362105007Temporary Cylinder ScrewMUATWTOXPMUATWTOXP2026-04-07
08800362105014Temporary Cylinder ScrewMUATWUNIPMUATWUNIP2026-04-07
08800362105021Final Cylinder ScrewMUAFW120MUAFW1202026-04-07
08800362105038Final Cylinder ScrewMUAFW123MUAFW1232026-04-07
08800362105045Final Cylinder ScrewMUAFW127MUAFW1272026-04-07
08800362105052Final Cylinder ScrewMUAFWTOXMUAFWTOX2026-04-07
08800362105069Final Cylinder ScrewMUAFWUNIMUAFWUNI2026-04-07
08800362105076Final Cylinder ScrewMUAFW120PMUAFW120P2026-04-07
08800362105083Final Cylinder ScrewMUAFW123PMUAFW123P2026-04-07
08800362105090Final Cylinder ScrewMUAFW127PMUAFW127P2026-04-07
08800362105106Final Cylinder ScrewMUAFWTOXPMUAFWTOXP2026-04-07
08800362105113Final Cylinder ScrewMUAFWUNIPMUAFWUNIP2026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11