FDA.reportPublic FDA data

Healing Abutment

Primary DI
08800293000471
Brand
Healing Abutment
Company
Megagen Implant Co. Ltd
Model
AROHSN50655N
Catalog number
AROHSN50655NT
Device description
BLUEDIAMOND
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800293000471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800293000471088002930004718800293000471

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
08800352213811Fixture DriverARFDUARFDU2026-05-26
08800352213828Fixture DriverARFDSARFDS2026-05-26
08800352213835Fixture DriverARFDLARFDL2026-05-26
08800292994085Impression CopingAONIP5009HAONIP5009HT2026-04-30
08800292994092Impression CopingAONIP5012HAONIP5012HT2026-04-30
08800292994108Impression CopingAONIP5015HAONIP5015HT2026-04-30
08800292994115Impression CopingAONIP6009HAONIP6009HT2026-04-30
08800292994122Impression CopingAONIP6012HAONIP6012HT2026-04-30
08800292994139Impression CopingAONIP6015HAONIP6015HT2026-04-30
08800292994412Impression CopingARIENIPN5009ARIENIPN5009T2026-04-30
08800292994429Impression CopingARIENIPN5012ARIENIPN5012T2026-04-30
08800292994436Impression CopingARIENIPN5015ARIENIPN5015T2026-04-30
08800292994443Impression CopingAONIP5009NAONIP5009NT2026-04-30
08800292994450Impression CopingAONIP5012NAONIP5012NT2026-04-30
08800292994467Impression CopingAONIP5015NAONIP5015NT2026-04-30
08800292994474Impression CopingAONIP6009NAONIP6009NT2026-04-30
08800292994481Impression CopingAONIP6012NAONIP6012NT2026-04-30
08800292994498Impression CopingAONIP6015NAONIP6015NT2026-04-30
08809822769964N2N2 (Cart A Type)MC92-0001A2023-11-22
08809822769971N2N2 (Mount A Type)MC92-0002A2023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
00842092187661PreatPreat CorporationNHA2026-04-30
00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24
00842092129210PreatPreat CorporationNHA2022-10-24
07630031717757Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic CopingInstitut Straumann AGNHA2022-04-14
07630031701565Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701572Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701602Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701619Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701626Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701633Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701640Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11