FDA.reportPublic FDA data

Temporary Cylinder Screw

Primary DI
08800362104987
Brand
Temporary Cylinder Screw
Company
DIMPLO Ltd.
Model
MUATW123P
Catalog number
MUATW123P
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
08800362104987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800362104987088003621049878800362104987

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. 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
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
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
08800362105120Healing CapMUAHC01MUAHC012026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516877992SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878005SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878012SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878029SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878036SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878043SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878050SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878067SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878074SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878081SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878098SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878104SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878111SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878128SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878135SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878142SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878159SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878166SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878173SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878180SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04099797001099CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001105CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001112CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001129CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001136CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001143CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001150CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001167CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001174CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001181CONELOG® Healing capALTATEC GmbHNHA2026-08-17