FDA.reportPublic FDA data

Multi-unit Angled Abutment

Primary DI
08806388243310
Brand
Multi-unit Angled Abutment
Company
Megagen Implant Co. Ltd
Model
MUAAEH1730
Catalog number
MUAAEH1730TC
Device description
C=3/ A=17/ Hex 2.7
Published
2021-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DHASystem, Test, Human Chorionic Gonadotropin
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203554000AnyOne External Implant SystemMegagen Implant Co., Ltd.2021-08-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388243310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388243310088063882433108806388243310

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
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08800292994092Impression CopingAONIP5012HAONIP5012HT2026-04-30
08800292994108Impression CopingAONIP5015HAONIP5015HT2026-04-30
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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

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