FDA.reportPublic FDA data

J2I Implant System

Primary DI
08809488219780
Brand
J2I Implant System
Company
KJMEDITECH.CO.,LTD
Model
ITPA6555
Device description
J2I Implant System/Two Piece Abutment
Published
2019-11-11
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
K140052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140052000J2I IMPLANT SYSTEMKj Meditech Co., Ltd.2014-10-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809488219780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809488219780088094882197808809488219780

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
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05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
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05712821014887Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014894Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014900Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
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05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014948Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
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05712821014962Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014979Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014986Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06