FDA.reportPublic FDA data

8plant Implant System

Primary DI
08800096851423
Brand
8plant Implant System
Company
8dent Inc.
Model
SUHLR7005
Device description
8plant Implant System
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K231426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2314260008plant Implant SystemHoowon Edi Co., Ltd.2024-05-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800096851423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800096851423088000968514238800096851423

GMDN Terms#

Term, Definition table
TermDefinition
Transmandibular implantA sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. It is composed of a metal plate and transosteal pins or posts. The plate is held with retentive pins or screws fixed to the inferior border of the mandible, and supports the transosteal pins/posts that penetrate the full thickness of the mandible and project into the mouth in the inter-foraminal area.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694477724
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088000968514098plant Implant SystemSUHLR70072026-10-23
088000968514168plant Implant SystemSUHLR70092026-10-23
088000968515468plant Implant SystemSUHLR80052026-10-23
088000968582178plant Implant SystemSUHLR70032026-10-23
088000968582248plant Implant SystemSUHLR70042026-10-23
088000968582318plant Implant SystemSUHLR70062026-10-23
088000968585528plant Implant SystemSUOPR5040402026-10-23
088000968587058plant Implant SystemSUOPM4540102026-10-23
088000968599008plant Implant SystemSUOPR5040102026-10-23
088000968600298plant Implant SystemSUOPM4555502026-10-23
088000968600508plant Implant SystemSUOPR4540102026-10-23
088000968601808plant Implant SystemSUOPR4055202026-10-23
088000968602038plant Implant SystemSUOPM4055202026-10-23
088000968608768plant Implant SystemSUOPM4040102026-10-23
088000968611948plant Implant SystemSUOPM4055102026-10-23
088000968617368plant Implant SystemSUOPM4555402026-10-23
088000968617438plant Implant SystemSUOPM4570502026-10-23
088000968618288plant Implant SystemSUOPR5040302026-10-23
088000968618358plant Implant SystemSUOPR5040502026-10-23
088000968620098plant Implant SystemSUOPM4540402026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23
088000968582178plant Implant System8dent Inc.NHA2026-10-23
088000968582248plant Implant System8dent Inc.NHA2026-10-23
088000968582318plant Implant System8dent Inc.NHA2026-10-23
088000968585528plant Implant System8dent Inc.NHA2026-10-23
088000968587058plant Implant System8dent Inc.NHA2026-10-23
088000968599008plant Implant System8dent Inc.NHA2026-10-23
088000968600298plant Implant System8dent Inc.NHA2026-10-23
088000968600508plant Implant System8dent Inc.NHA2026-10-23
088000968601808plant Implant System8dent Inc.NHA2026-10-23
088000968602038plant Implant System8dent Inc.NHA2026-10-23
088000968608768plant Implant System8dent Inc.NHA2026-10-23
088000968611948plant Implant System8dent Inc.NHA2026-10-23
088000968617368plant Implant System8dent Inc.NHA2026-10-23
088000968617438plant Implant System8dent Inc.NHA2026-10-23
088000968618288plant Implant System8dent Inc.NHA2026-10-23
088000968618358plant Implant System8dent Inc.NHA2026-10-23
088000968620098plant Implant System8dent Inc.NHA2026-10-23
088000968620168plant Implant System8dent Inc.NHA2026-10-23
088000968620238plant Implant System8dent Inc.NHA2026-10-23
088000968622698plant Implant System8dent Inc.NHA2026-10-23
088000968622768plant Implant System8dent Inc.NHA2026-10-23
088000968650248plant Implant System8dent Inc.NHA2026-10-23
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
088000968788408plant Implant System8dent Inc.NHA2026-10-23