FDA.reportPublic FDA data

J2R Implant System

Primary DI
08809488217533
Brand
J2R Implant System
Company
KJMEDITECH.CO.,LTD
Model
JRF4311
Device description
J2R Implant System/Fixture
Published
2019-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130694000JR IMPLANT SYSTEMLK Consulting Group USA, Inc.2014-06-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809488217533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809488217533088094882175338809488217533

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688476027
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28