FDA.reportPublic FDA data

DIMPLO Fixture

Primary DI
08800362100002
Brand
DIMPLO Fixture
Company
DIMPLO Ltd.
Model
DFM3008
Catalog number
DFM3008
Published
2026-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
08800362100002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800362100002088003621000028800362100002

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963392194
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06