FDA.reportPublic FDA data

ARi ExCon Implant

Primary DI
08809854028565
Brand
ARi ExCon Implant
Company
Megagen Implant Co. Ltd
Model
ARIE283574
Catalog number
ARIE283574M
Published
2024-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230618000
K231967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230618000MegaGen Dental Implant Systems Portfolio - MR ConditionalMegagen Implant Co., Ltd.2023-10-11DZE
K231967000ARi ExCon Implant SystemMegagen Implant Co., Ltd.2023-12-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809854028565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809854028565088098540285658809854028565

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

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
08806388205226Esthetic Healing AbutmentAEHR402AEHR4022021-11-18
08806388205233Esthetic Healing AbutmentAEHR403AEHR4032021-11-18
08806388205240Esthetic Healing AbutmentAEHR404AEHR4042021-11-18
08806388205257Esthetic Healing AbutmentAEHS302AEHS3022021-11-18
08806388205264Esthetic Healing AbutmentAEHS303AEHS3032021-11-18
08806388205271Esthetic Healing AbutmentAEHS304AEHS3042021-11-18
08806388205288Esthetic Healing AbutmentAEHW502AEHW5022021-11-18
08806388205295Esthetic Healing AbutmentAEHW503AEHW5032021-11-18
08806388205301Esthetic Healing AbutmentAEHW504AEHW5042021-11-18
08806388213023AnyOne External FixtureEF3507EF3507P2021-11-18
08806388213047AnyOne External FixtureEF3508EF3508P2021-11-18
08806388213061AnyOne External FixtureEF3510EF3510P2021-11-18
08806388213085AnyOne External FixtureEF3511EF3511P2021-11-18
08806388213108AnyOne External FixtureEF3513EF3513P2021-11-18
08806388213122AnyOne External FixtureEF3515EF3515P2021-11-18
08806388213146AnyOne External FixtureEF4007EF4007P2021-11-18
08806388213160AnyOne External FixtureEF4008EF4008P2021-11-18
08806388213184AnyOne External FixtureEF4010EF4010P2021-11-18
08806388213207AnyOne External FixtureEF4011EF4011P2021-11-18
08806388213221AnyOne External FixtureEF4013EF4013P2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767960AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767977AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767984AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12