FDA.report

LW Solid Abutment

Primary DI
08809877413652
Brand
LW Solid Abutment
Company
Ossvis Co., Ltd.
Model
LWSA6557PC
Device description
Dental Implant Abutment
Published
2024-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions

SubmissionSupplement
K233167000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809877413652PrimaryGS10

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
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
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08809918274020LL Scan BodyLLMFSBPE2025-06-26
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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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