FDA.reportPublic FDA data

JDZygoma

Primary DI
08055510175085
Brand
JDZygoma
Company
J DENTAL CARE SRL
Model
Screw for 60° Angulated Conical Abutment JDEvoluti
Catalog number
EVCASA60:
Device description
Screw for 60° Angulated Conical Abutment JDEvolution Plus
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K240143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240143000JDZygoma dental implantsJdentalcare Srl2024-10-11DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055510175085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055510175085080555101750858055510175085

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
+39059454255a.grandi@jdentalcare.com

Regulatory Flags#

DUNS number
428716597
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
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
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
08800292991923Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991930Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03