FDA.reportPublic FDA data

S-Plant

Primary DI
08809984970437
Brand
S-Plant
Company
IDIS CO.,LTD
Model
ISH401M
Device description
S-Plant healing abutment, Mini connection. Non-anodized titanium alloy (Ti-6Al-4V ELI, ASTM F136). Used temporarily to shape soft tissue after osseointegration and before placement of the definitive prosthesis. Supplied non-sterile; steam sterilization is required before use. Nominal diameter 4.0 mm; overall length 8.7 mm; gingival height (GH) 1.0 mm.
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K231429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231429000S-Plant Dental Implant SystemIdis Co., Ltd.2023-12-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809984970437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809984970437088099849704378809984970437

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695010523
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809984970444S-PlantISH402M2026-10-23
08809984970451S-PlantISH403M2026-10-23
08809984970468S-PlantISH404M2026-10-23
08809984970475S-PlantISH405M2026-10-23
08809984970505S-PlantISH451M2026-10-23
08809984970512S-PlantISH452M2026-10-23
08809984970529S-PlantISH453M2026-10-23
08809984970536S-PlantISH454M2026-10-23
08809984970543S-PlantISH455M2026-10-23
08809984970642S-PlantISH4512026-10-23
08809984970659S-PlantISH4522026-10-23
08809984970666S-PlantISH4532026-10-23
08809984970673S-PlantISH4542026-10-23
08809984970680S-PlantISH4552026-10-23
08809984970710S-PlantISH5012026-10-23
08809984970727S-PlantISH5022026-10-23
08809984970734S-PlantISH5032026-10-23
08809984970741S-PlantISH5042026-10-23
08809984970758S-PlantISH5052026-10-23
08809984970789S-PlantISH6012026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088000968622698plant Implant System8dent Inc.NHA2026-10-23
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088000968650798plant Implant System8dent Inc.NHA2026-10-23
088000968688418plant Implant System8dent Inc.NHA2026-10-23
088000968688588plant Implant System8dent Inc.NHA2026-10-23
088000968788338plant Implant System8dent Inc.NHA2026-10-23