FDA.reportPublic FDA data

LW Solid Abutment

Primary DI
08809918213418
Brand
LW Solid Abutment
Company
Ossvis Co., Ltd.
Model
LWSA5027FC
Device description
Dental Implant Abutment
Published
2024-05-20
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
K233167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233167000LW Implant System – AbutmentOssvis Co., Ltd.2024-03-25NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918213418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918213418088099182134188809918213418

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
08809918274143LW Digital Lab Analog GMLWSDLAGM2026-04-20
08809918274150LW Narrow Dirigal Lab Analog GMLWNDLAGM2026-04-20
08809918274136Screw Remover TipHSRT2026-03-12
08809918274013LL Scan BodyLLMFSB2025-12-31
08809918259997LL Driver SeparatorHLLFRP2025-12-15
08809918274037Guide Full Flattening DrillHFD50GF2025-12-15
08809918274044Guide Full Lindemann DrillHLD1807GF2025-12-15
08809918274051Guide Full Lindemann DrillHLD1808GF2025-12-15
08809918274068Guide Full Lindemann DrillHLD1810GF2025-12-15
08809918274075Guide Full Lindemann DrillHLD1811GF2025-12-15
08809918274082Guide Full Lindemann DrillHLD1813GF2025-12-15
08809918274099Guide Full Cortical DrillHCD50GF2025-12-15
08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
08809918274112Guide Full NoMount Driver EngineHNNRSEGF2025-12-15
08809918274129Guide Full Anchor Driver EngineHARSEGF2025-12-15
08809918274020LL Scan BodyLLMFSBPE2025-06-26
08809918209756LW Pre-milled AbutmentLWDPA1040HDB2024-12-18
08809918209763LW Pre-milled AbutmentLWDPA1040NDB2024-12-18
08809918209770LW Pre-milled AbutmentLWDPA1040HMX2024-12-18
08809918209787LW Pre-milled AbutmentLWDPA1040NMX2024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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