FDA.reportPublic FDA data

i-Gen

Primary DI
08806388221677
Brand
i-Gen
Company
Megagen Implant Co. Ltd
Model
IG1W5510
Catalog number
IG1W5510
Device description
i-Gen Type A2
Published
2015-06-25
Public version status
Update
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
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131289000I-GENMegagen Implant Co., Ltd.2013-09-25JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388221677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388221677088063882216778806388221677

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, metallicA sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.

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
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11