FDA.reportPublic FDA data

JDIcon

Primary DI
08055510175283
Brand
JDIcon
Company
J DENTAL CARE SRL
Model
JDIcon D 4.3 L 11.5
Catalog number
IC43115
Device description
JDIcon D 4.3 L 11.5
Published
2020-07-28
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

Contact Domains#

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
K182081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182081000JDentalCare Implant System JDIconJdentalcare Srl2020-06-26DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055510175283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055510175283080555101752838055510175283

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.5Millimeter
Outer Diameter4.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39059454255g.grandi@jdentalcare.com

Regulatory Flags#

DUNS number
428716597
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056591027355JDEvolution SImplant Mounter Long for JDEvolution SESGMLC2026-05-25
08056591028710JDIcon PlusImplant Driver for Guided Surgery JDIcon PlusICIDGS.2026-05-06
08056591027652JDEvolution PlusHealing Abutment Ø 4.0 H 1.0 JDEvolution PlusEVHA41:2026-03-31
08056591027669JDEvolution PlusHealing Abutment Ø 4.0 H 2.0 JDEvolution PlusEVHA42:2026-03-31
08056591028840JDentalCare Prosthetic ScrewProsthetic Screw Conical Abutment Direct NEVCAPSN:2026-03-30
08056591028833JDentalCare Dental InstrumentsFull Arch KitJDFABRK2026-02-24
08056591013624JDentalCare Dental InstrumentsConical Abutment Aligning Instrument JDIcon PlusJDID1052026-01-23
08056591024453JDentalCare Dental InstrumentsProsthetic Driver for Surgical DriverJDPD1032026-01-15
08056591024477JDentalCare Dental InstrumentsProsthetic Driver JDEvolution Plus for Surgical DrJDPD1052026-01-15
08056591027713JDZygomaJDZygoma Ø 3.9 L 32.5ZY39325:2026-01-07
08056591028321JDentalCare Conical AbutmentsScanBody Conical Abutment MINIEVCASBCEMIC2025-12-11
08056591028338JDentalCare Conical AbutmentsScanBody Engaging Conical Abutment MINIEVCASBCEMIEC2025-12-11
08056591028345JDentalCare Conical AbutmentsConical Abutment MINI Impression Coping Open TrayEVCAICOTMIC2025-12-11
08056591028352JDentalCare Conical AbutmentsConical Abutment MINI Impression Coping Engaging OEVCAICOTMIEC2025-12-11
08056591028369JDentalCare Conical AbutmentsConical Abutment MINI ReplicaEVCAARMI2025-12-11
08056591028376JDentalCare Conical AbutmentsConical Abutment MINI Replica CAD CAMEVCAARMIC2025-12-11
08056591028383JDentalCare Conical AbutmentsOn Top ScanBody Conical Abutment MINIEVCASBCESMIC:2025-12-11
08056591028512JDEvolution PlusScanBody Conical Abutment MINI JDEvolution PlusEVCASBCEMIC:2025-12-11
08056591028529JDEvolution PlusScanBody Engaging Conical Abutment MINI JDEvolutioEVCASBCEMIEC:2025-12-11
08056591028536JDEvolution PlusConical Abutment MINI Impression Coping Open Tray EVCAICOTMIC:2025-12-11

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