FDA.reportPublic FDA data

Highness Implant System

Primary DI
08800108361094
Brand
Highness Implant System
Company
highness Co., Ltd.
Model
SSA4035B
Device description
Non-sterile dental implant abutment intended to connect a dental implant fixture to a prosthetic restoration. Made of titanium alloy with a machined surface
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K240383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240383000Highness Implant SystemHighness Co., Ltd.2024-10-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800108361094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800108361094088001083610948800108361094

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

Regulatory Flags#

DUNS number
695930212
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800108301663Highness Implant SystemSHA40302B2025-12-24
08800108301687Highness Implant SystemSHA40402B2025-12-24
08800108301700Highness Implant SystemSHA40502B2025-12-24
08800108301724Highness Implant SystemSHA40602B2025-12-24
08800108301748Highness Implant SystemSHA40702B2025-12-24
08800108301854Highness Implant SystemSHA45602B2025-12-24
08800108301960Highness Implant SystemSHA50602B2025-12-24
08800108302073Highness Implant SystemSHA55602B2025-12-24
08800108302189Highness Implant SystemSHA60602B2025-12-24
08800108302295Highness Implant SystemSHA65602B2025-12-24
08800108306828Highness Implant SystemSCA5555B2025-12-24
08800108311976Highness Implant SystemSHA45302B2025-12-24
08800108311983Highness Implant SystemSHA45402B2025-12-24
08800108312003Highness Implant SystemSHA45702B2025-12-24
08800108312041Highness Implant SystemSHA50302B2025-12-24
08800108312058Highness Implant SystemSHA50402B2025-12-24
08800108312065Highness Implant SystemSHA50502B2025-12-24
08800108312072Highness Implant SystemSHA50702B2025-12-24
08800108312119Highness Implant SystemSHA55302B2025-12-24
08800108312126Highness Implant SystemSHA55402B2025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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