FDA.reportPublic FDA data

LW Narrow Implant

Primary DI
08809918260016
Brand
LW Narrow Implant
Company
Ossvis Co., Ltd.
Model
LWNF3510SC
Device description
Submerged Dental Implant
Published
2024-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K233808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233808000LW Narrow Implant SystemOssvis Co., Ltd.2024-07-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918260016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918260016088099182600168809918260016

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.

Regulatory Flags#

DUNS number
695365503
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136385Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136392Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
08809984970284S-PlantIDIS CO.,LTDDZE2026-10-21
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08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
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08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20