FDA.reportPublic FDA data

8plant Implant System

Primary DI
08800096868605
Brand
8plant Implant System
Company
8dent Inc.
Model
SUTPM405540HE
Device description
8plant Implant System
Published
2026-11-04
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
08800096868605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800096868605088000968686058800096868605

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
088000968582008plant Implant SystemSUTPM405520HE2026-11-04
088000968584398plant Implant SystemSUTPM407030HE2026-11-04
088000968586998plant Implant SystemSUTPM405550HE2026-11-04
088000968602108plant Implant SystemSUTPM407010HE2026-11-04
088000968602278plant Implant SystemSUTPM407020HE2026-11-04
088000968612318plant Implant SystemSUTPM404040HE2026-11-04
088000968612488plant Implant SystemSUTPM404050HE2026-11-04
088000968622908plant Implant SystemSUTPM405530HE2026-11-04
088000968788578plant Implant SystemSUTPM405510HE2026-11-04
088000968612008plant Implant SystemSUTPM404010HE2026-10-29
088000968612178plant Implant SystemSUTPM404020HE2026-10-29
088000968612248plant Implant SystemSUTPM404030HE2026-10-29
088000968582488plant Implant SystemSULOR602026-10-28
088000968583238plant Implant SystemSULOR302026-10-28
088000968583308plant Implant SystemSULOR502026-10-28
088000968583548plant Implant SystemSULOR102026-10-28
088000968583618plant Implant SystemSULOR402026-10-28
088000968583928plant Implant SystemSULOR202026-10-28
088000968585218plant Implant SystemSUOPR5055402026-10-28
088000968585388plant Implant SystemSUOPR5055502026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582008plant Implant System8dent Inc.NHA2026-11-04
088000968584398plant Implant System8dent Inc.NHA2026-11-04
088000968586998plant Implant System8dent Inc.NHA2026-11-04
088000968602108plant Implant System8dent Inc.NHA2026-11-04
088000968602278plant Implant System8dent Inc.NHA2026-11-04
088000968612318plant Implant System8dent Inc.NHA2026-11-04
088000968612488plant Implant System8dent Inc.NHA2026-11-04
088000968622908plant Implant System8dent Inc.NHA2026-11-04
088000968788578plant Implant System8dent Inc.NHA2026-11-04
00840481137181LOCATOR Angled AbutmentZest Anchors, LLCNHA2026-11-03
08800077020022ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020053ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020640ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020657ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020664ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020671ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020688ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020695ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020701ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020718ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020725ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020732ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020749ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020756ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020763ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020770ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020787ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020794ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020800ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020817ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30