FDA.reportPublic FDA data

JDEvolution S

Primary DI
08055510170998
Brand
JDEvolution S
Company
J DENTAL CARE SRL
Model
Healing Abutment D 4.0 H 7.0 JDEvolution S
Catalog number
ESHA407
Device description
Healing Abutment D 4.0 H 7.0 JDEvolution S
Published
2018-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K143142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143142000JDENTALCARE Implant SystemJdentalcare Srl2015-11-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055510170998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055510170998080555101709988055510170998

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
428716597
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056591028154JDentalCare Dental InstrumentsJD Bone Leveling DrillJDBLDR2026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22