FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08809737575544
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
ISAHMUA1420S
Device description
Ø4.8*2.0mm, 17°, Hex
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K210903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210903000IS Multi Unit Abutment SystemNeobiotech Co., Ltd.2021-07-23NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809737575544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809737575544088097375755448809737575544

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688371566
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800394921170Neobiotech Implant SystemBTPCIB35022026-09-22
08800394921187Neobiotech Implant SystemBTPCIB35032026-09-22
08800394921194Neobiotech Implant SystemBTPCIB35042026-09-22
08800394921200Neobiotech Implant SystemBTPCIB48022026-09-22
08800394921217Neobiotech Implant SystemBTPCIB48032026-09-22
08800394921224Neobiotech Implant SystemBTPCIB48042026-09-22
08800394921231Neobiotech Implant SystemBTPCI3502C2026-09-22
08800394921248Neobiotech Implant SystemBTPCI3503C2026-09-22
08800394921255Neobiotech Implant SystemBTPCI3504C2026-09-22
08800394921262Neobiotech Implant SystemBTPCI4802C2026-09-22
08800394921279Neobiotech Implant SystemBTPCI4803C2026-09-22
08800394921286Neobiotech Implant SystemBTPCI4804C2026-09-22
08800394921293Neobiotech Implant SystemALXMAXY322026-09-22
08800394921309Neobiotech Implant SystemATD2528142026-09-22
08800394921316Neobiotech Implant SystemATSD2532082026-09-22
08800394921323Neobiotech Implant SystemATSD2532102026-09-22
08800394921330Neobiotech Implant SystemATSD2532122026-09-22
08800394921347Neobiotech Implant SystemATSD3235082026-09-22
08800394921354Neobiotech Implant SystemATSD3235102026-09-22
08800394921361Neobiotech Implant SystemATSD3542082026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18