FDA.reportPublic FDA data

LW Vis Abutment

Primary DI
08809918226890
Brand
LW Vis Abutment
Company
Ossvis Co., Ltd.
Model
LWCA6075FNS
Device description
Dental Implant Abutment
Published
2023-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
K223924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223924000LW Implant SystemOssvis Co., Ltd.2023-08-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918226890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918226890088099182268908809918226890

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695365503
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809918260054LW Narrow Solid AbutmentLWNSA4014F2026-10-22
08809918260085LW Narrow Solid AbutmentLWNSA4015F2026-10-22
08809918259713LW OSS Abutment Lab AnalogLWOLA452026-10-13
08809918259720LW OSS Abutment Lab AnalogLWOLA552026-10-13
08809918261693LW Narrow Angled AbutmentLWNAA40225FHACS2026-08-13
08809918261815LW Narrow Angled AbutmentLWNAA40225FNCS2026-08-13
08809918262416LW Narrow Angled AbutmentLWNAA40425FHACS2026-08-13
08809918262539LW Narrow Angled AbutmentLWNAA40425FNCS2026-08-13
08809918263130LW Narrow Angled AbutmentLWNAA45225FHACS2026-08-13
08809918263253LW Narrow Angled AbutmentLWNAA45225FNCS2026-08-13
08809918263857LW Narrow Angled AbutmentLWNAA45425FHACS2026-08-13
08809918263970LW Narrow Angled AbutmentLWNAA45425FNCS2026-08-13
08809918255203LW Narrow Pre-milled AbutmentLWNDPA1040HDB2024-12-18
08809918255210LW Narrow Pre-milled AbutmentLWNDPA1040HDBS2024-12-18
08809918255227LW Narrow Pre-milled AbutmentLWNDPA1040HMX2024-12-18
08809918255234LW Narrow Pre-milled AbutmentLWNDPA1040HMXS2024-12-18
08809918255241LW Narrow Pre-milled AbutmentLWNDPA1040NDB2024-12-18
08809918255258LW Narrow Pre-milled AbutmentLWNDPA1040NDBS2024-12-18
08809918255265LW Narrow Pre-milled AbutmentLWNDPA1040NMX2024-12-18
08809918255272LW Narrow Pre-milled AbutmentLWNDPA1040NMXS2024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968612008plant Implant System8dent Inc.NHA2026-10-29
088000968612178plant Implant System8dent Inc.NHA2026-10-29
088000968612248plant Implant System8dent Inc.NHA2026-10-29
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23