FDA.reportPublic FDA data

JDZygoma

Primary DI
08055510176822
Brand
JDZygoma
Company
J DENTAL CARE SRL
Model
JDZygoma Ø 4.3 L 40
Catalog number
ZY43400:
Device description
JDZygoma Ø 4.3 L 40
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
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
08055510176822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055510176822080555101768228055510176822

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

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
Expiration date on label
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
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04