FDA.reportPublic FDA data

Healing Abutment

Primary DI
08806388286355
Brand
Healing Abutment
Company
Megagen Implant Co. Ltd
Model
AOHI60504
Catalog number
AOHI60504T
Device description
AnyOne Internal & ST Implant System(I3) I/ M6/ L5/ H=4/ Hex
Published
2023-05-30
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
08806388286355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388286355088063882863558806388286355

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
08806388266173ZrGEN AbutmentARZXM503825ARZXM503825.MTN2024-01-31
08806388244812ZrGEN AbutmentARZXM5015ARZXM5015.MTN2023-06-22
08806388244829ZrGEN AbutmentARZXM5525ARZXM5525.MTN2023-06-22
08806388244836ZrGEN AbutmentARZXM5016ARZXM5016.MTN2023-06-22
08806388244843ZrGEN AbutmentARZXM5526ARZXM5526.MTN2023-06-22
08806388244850ZrGEN AbutmentARZXM5015NARZXM5015N.MTN2023-06-22
08806388244867ZrGEN AbutmentARZXM5525NARZXM5525N.MTN2023-06-22
08806388244874ZrGEN AbutmentARZXM5016NARZXM5016N.MTN2023-06-22
08806388244898ZrGEN AbutmentARZXL5515ARZXL5515.MTN2023-06-22
08806388244904ZrGEN AbutmentARZXL6025ARZXL6025.MTN2023-06-22
08806388244911ZrGEN AbutmentARZXL5516ARZXL5516.MTN2023-06-22
08806388244928ZrGEN AbutmentARZXL6026ARZXL6026.MTN2023-06-22
08806388244935ZrGEN AbutmentARZXL5515NARZXL5515N.MTN2023-06-22
08806388244942ZrGEN AbutmentARZXL6025NARZXL6025N.MTN2023-06-22
08806388244959ZrGEN AbutmentARZXL5516NARZXL5516N.MTN2023-06-22
08806388244966ZrGEN AbutmentARZXL6026NARZXL6026N.MTN2023-06-22
08806388256624ZrGEN AbutmentAROZGN4015AROZGN4015T2023-06-22
08806388256631ZrGEN AbutmentAROZGN4025AROZGN4025T2023-06-22
08806388256648ZrGEN AbutmentAROZGR4515AROZGR4515T2023-06-22
08806388256655ZrGEN AbutmentAROZGR4525AROZGR4525T2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22