FDA.reportPublic FDA data

Healing Abutment

Primary DI
08806388293308
Brand
Healing Abutment
Company
Megagen Implant Co. Ltd
Model
AROHMR70905N
Catalog number
AROHMR70905NT
Device description
BLUEDIAMOND Implant System (M5) M/ M7/ L9/ H=5/ Non-Octa
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K210826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210826000Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.2022-02-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388293308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388293308088063882933088806388293308

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

Regulatory Flags#

DUNS number
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388287857Healing AbutmentAOHS50704AOHS50704T2023-06-30
08806388287819Healing AbutmentAOHS50655AOHS50655T2023-06-08
08806388287826Healing AbutmentAOHS50657AOHS50657T2023-06-08
08806388287833Healing AbutmentAOHS50702AOHS50702T2023-06-08
08806388287840Healing AbutmentAOHS50703AOHS50703T2023-06-08
08806388287864Healing AbutmentAOHS50705AOHS50705T2023-06-08
08806388287871Healing AbutmentAOHS50707AOHS50707T2023-06-08
08806388287888Healing AbutmentAOHS60702AOHS60702T2023-06-08
08806388287895Healing AbutmentAOHS60703AOHS60703T2023-06-08
08806388287901Healing AbutmentAOHS60704AOHS60704T2023-06-08
08806388287918Healing AbutmentAOHS60705AOHS60705T2023-06-08
08806388287925Healing AbutmentAOHS60707AOHS60707T2023-06-08
08806388287932Healing AbutmentAOHS60802AOHS60802T2023-06-08
08806388287949Healing AbutmentAOHS60803AOHS60803T2023-06-08
08806388288359Healing AbutmentAOHS50654NAOHS50654NT2023-06-08
08806388288366Healing AbutmentAOHS50655NAOHS50655NT2023-06-08
08806388288373Healing AbutmentAOHS50657NAOHS50657NT2023-06-08
08806388288380Healing AbutmentAOHS50702NAOHS50702NT2023-06-08
08806388288397Healing AbutmentAOHS50703NAOHS50703NT2023-06-08
08806388288403Healing AbutmentAOHS50704NAOHS50704NT2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
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07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
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07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
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