FDA.reportPublic FDA data

S-Plant

Primary DI
08809984988067
Brand
S-Plant
Company
IDIS CO.,LTD
Model
PISD4057HM
Device description
Non-sterile, single-use, preformed dual dental implant abutment made of Ti-6Al-4V ELI alloy (ASTM F136), with a TiN coating and a Mini connection. Requires steam sterilization before use.
Published
2026-10-21
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
08809984988067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809984988067088099849880678809984988067

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
08809984988135S-PlantPISD4517HM2026-10-22
08809984988210S-PlantPISD4527HM2026-10-22
08809984988296S-PlantPISD4537HM2026-10-22
08809984988333S-PlantPISD4545HM2026-10-22
08809984988371S-PlantPISD4547HM2026-10-22
08809984988418S-PlantPISD4555HM2026-10-22
08809984988456S-PlantPISD4557HM2026-10-22
08809984970284S-PlantSPFS5007R2026-10-21
08809984970291S-PlantSPFS5008R2026-10-21
08809984970307S-PlantSPFS5010R2026-10-21
08809984970314S-PlantSPFS5011R2026-10-21
08809984970345S-PlantSPFS6007W2026-10-21
08809984970352S-PlantSPFS6008W2026-10-21
08809984970369S-PlantSPFS6010W2026-10-21
08809984970376S-PlantSPFS6011W2026-10-21
08809984970390S-PlantSPFS7007W2026-10-21
08809984970406S-PlantSPFS7008W2026-10-21
08809984987886S-PlantPISD4015HM2026-10-21
08809984987909S-PlantPISD4017HM2026-10-21
08809984987923S-PlantPISD4025HM2026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809918260054LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809918260085LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809984988135S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988210S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988296S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988333S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988371S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988418S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988456S-PlantIDIS CO.,LTDNHA2026-10-22
08809984987886S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987909S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987923S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987947S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987961S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987985S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988005S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988029S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988043S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988098S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988173S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988258S-PlantIDIS CO.,LTDNHA2026-10-21
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20