FDA.reportPublic FDA data

S-Plant

Primary DI
08809984970178
Brand
S-Plant
Company
IDIS CO.,LTD
Model
SPFS4008R
Device description
Sterile, single-use dental implant fixture made of commercially pure titanium (Grade 4), with an SLA-treated surface.
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
08809984970178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809984970178088099849701788809984970178

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.

Device Sizes#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809984970062S-PlantSPFS3310M2026-10-20
08809984970079S-PlantSPFS3311M2026-10-20
08809984970086S-PlantSPFS3313M2026-10-20
08809984970093S-PlantSPFS3315M2026-10-20
08809984970109S-PlantSPFS3607R2026-10-20
08809984970116S-PlantSPFS3608R2026-10-20
08809984970123S-PlantSPFS3610R2026-10-20
08809984970130S-PlantSPFS3611R2026-10-20
08809984970147S-PlantSPFS3613R2026-10-20
08809984970154S-PlantSPFS3615R2026-10-20
08809984970161S-PlantSPFS4007R2026-10-20
08809984970185S-PlantSPFS4010R2026-10-20
08809984970192S-PlantSPFS4011R2026-10-20
08809984970208S-PlantSPFS4013R2026-10-20
08809984970222S-PlantSPFS4507R2026-10-20
08809984970239S-PlantSPFS4508R2026-10-20
08809984970246S-PlantSPFS4510R2026-10-20
08809984970253S-PlantSPFS4511R2026-10-20
08809984970260S-PlantSPFS4513R2026-10-20
08809984989040S-PlantPISD6055H2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970253S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970260S-PlantIDIS CO.,LTDDZE2026-10-20
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14