FDA.reportPublic FDA data

KJ Mini Implant System

Primary DI
08809702404428
Brand
KJ Mini Implant System
Company
KJMEDITECH.CO.,LTD
Model
MIAR4505A25
Device description
KJ Mini Implant System/Post Abutment
Published
2019-11-13
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
K151970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151970000KJ Mini Implant SystemKj Meditech Co., Ltd.2016-10-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809702404428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809702404428088097024044288809702404428

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
688476027
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809488210060ANCHOR PLUS/NEO ANCHOR PLUSMS-14062019-08-26
08809488210077ANCHOR PLUS/NEO ANCHOR PLUSMS-14072019-08-26
08809488210084ANCHOR PLUS/NEO ANCHOR PLUSMS-14082019-08-26
08809488210091ANCHOR PLUS/NEO ANCHOR PLUSMS-14102019-08-26
08809488210107ANCHOR PLUS/NEO ANCHOR PLUSMS-14122019-08-26
08809488210114ANCHOR PLUS/NEO ANCHOR PLUSMS-16062019-08-26
08809488210121ANCHOR PLUS/NEO ANCHOR PLUSMS-16072019-08-26
08809488210138ANCHOR PLUS/NEO ANCHOR PLUSMS-16082019-08-26
08809488210145ANCHOR PLUS/NEO ANCHOR PLUSMS-16102019-08-26
08809488210152ANCHOR PLUS/NEO ANCHOR PLUSMS-16122019-08-26
08809488210169ANCHOR PLUS/NEO ANCHOR PLUSMSS-14062019-08-26
08809488210176ANCHOR PLUS/NEO ANCHOR PLUSMSS-14072019-08-26
08809488210183ANCHOR PLUS/NEO ANCHOR PLUSMSS-14082019-08-26
08809488210190ANCHOR PLUS/NEO ANCHOR PLUSMSS-14102019-08-26
08809488210206ANCHOR PLUS/NEO ANCHOR PLUSMSS-14122019-08-26
08809488210213ANCHOR PLUS/NEO ANCHOR PLUSMSS-16062019-08-26
08809488210220ANCHOR PLUS/NEO ANCHOR PLUSMSS-16072019-08-26
08809488210237ANCHOR PLUS/NEO ANCHOR PLUSMSS-16082019-08-26
08809488210244ANCHOR PLUS/NEO ANCHOR PLUSMSS-16102019-08-26
08809488210251ANCHOR PLUS/NEO ANCHOR PLUSMSS-16122019-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04