FDA.reportPublic FDA data

KJ Mini Implant System

Primary DI
08809702406064
Brand
KJ Mini Implant System
Company
KJMEDITECH.CO.,LTD
Model
OATT
Device description
KJ Mini Implant System/Ball Attachments
Published
2019-11-21
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

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
08809702406064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809702406064088097024060648809702406064

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
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04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
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