FDA.report

LW Fixture

Primary DI
08809918254572
Brand
LW Fixture
Company
Ossvis Co., Ltd.
Model
PLWSF5007SC
Device description
Dental Implant Fixture
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K223924000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223924000LW Implant SystemOssvis Co., Ltd.2023-08-08DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809918254572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809918254572088099182545728809918254572

GMDN Terms

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

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
false
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

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08809918274099Guide Full Cortical DrillHCD50GF2025-12-15
08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
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08809918274129Guide Full Anchor Driver EngineHARSEGF2025-12-15
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