FDA.reportPublic FDA data

Healing Cap

Primary DI
08800362105120
Brand
Healing Cap
Company
DIMPLO Ltd.
Model
MUAHC01
Catalog number
MUAHC01
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
08800362105120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800362105120088003621051208800362105120

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
08800020806819SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806826SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806833SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806871SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806888SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806895SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807113SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807120SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807137SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807144SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807274SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807281SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807298SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807304SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840684SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840691SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840707SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840714SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840769SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840776SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841124SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841131SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841148SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841155SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841162SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841179SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04