FDA.reportPublic FDA data

Final Cylinder Screw

Primary DI
08800362105113
Brand
Final Cylinder Screw
Company
DIMPLO Ltd.
Model
MUAFWUNIP
Catalog number
MUAFWUNIP
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
08800362105113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800362105113088003621051138800362105113

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
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
08800362105120Healing CapMUAHC01MUAHC012026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216473ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216480ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216497ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216503ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216589ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216596ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216619ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18