FDA.reportPublic FDA data

LL Mini Onebody Implant

Primary DI
08809918255715
Brand
LL Mini Onebody Implant
Company
Ossvis Co., Ltd.
Model
LLMF301135S
Device description
Dental Implant Fixture
Published
2024-11-29
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
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242379000LL Implant SystemOssvis Co., Ltd.2024-11-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918255715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918255715088099182557158809918255715

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695365503
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809918273252LW Oss Abutment Driver EngineHLWORSE2024-10-25
08809918273269LW Oss Abutment Driver WrenchHLWORSW2024-10-25
08809918273436LW Oss Abutment Scan BodyLWOSB455HS2024-10-25
08809918273443LW Oss Abutment Scan BodyLWOSB455NS2024-10-25
08809918273450LW Oss Abutment Scan BodyLWOSB458HS2024-10-25
08809918273467LW Oss Abutment Scan BodyLWOSB458NS2024-10-25
08809918273474LW Oss Abutment Scan BodyLWOSB555HS2024-10-25
08809918273481LW Oss Abutment Scan BodyLWOSB555NS2024-10-25
08809918273498LW Oss Abutment Scan BodyLWOSB558HS2024-10-25
08809918273504LW Oss Abutment Scan BodyLWOSB558NS2024-10-25
08809918254947LW Oss Abutment Pick-up Impression CopingLWOPI45H2024-08-01
08809918254954LW Oss Abutment Pick-up Impression CopingLWOPI45HS2024-08-01
08809918254961LW Oss Abutment Pick-up Impression CopingLWOPI45N2024-08-01
08809918254978LW Oss Abutment Pick-up Impression CopingLWOPI45NS2024-08-01
08809918254985LW Oss Abutment Pick-up Impression CopingLWOPI55H2024-08-01
08809918254992LW Oss Abutment Pick-up Impression CopingLWOPI55HS2024-08-01
08809918255005LW Oss Abutment Pick-up Impression CopingLWOPI55N2024-08-01
08809918255012LW Oss Abutment Pick-up Impression CopingLWOPI55NS2024-08-01
08809918255029LW Oss Abutment Pick-up Impression Coping Guide PinLWOPIG2024-08-01
08809918255036LW Oss Abutment Transfer Impression CopingLWOTI45H2024-08-01

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