FDA.report

JDentalCare Dental Instruments

Primary DI
08056591010807
Brand
JDentalCare Dental Instruments
Company
J DENTAL CARE SRL
Model
Prosthetic Driver for JDTorque L 35 JDEvolution Pl
Catalog number
EVSDPF35:
Device description
Prosthetic Driver for JDTorque L 35 JDEvolution Plus
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08056591010807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056591010807080565910108078056591010807

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+39059454255g.grandi@jdentalcare.com

Regulatory Flags

DUNS number
428716597
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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08056591027355JDEvolution SImplant Mounter Long for JDEvolution SESGMLC2026-05-25
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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
08056591028543JDEvolution PlusConical Abutment MINI Impression Coping Engaging OEVCAICOTMIEC:2025-12-11
08056591028253JDentalCare Conical AbutmentsConical Abutment MINI Healing Cap EVCAHCMIC2025-12-10
08056591028260JDentalCare Conical AbutmentsConical Abutment MINI Healing Cap H 6.0 EVCAHCLMIC2025-12-10
08056591028277JDentalCare Conical AbutmentsInterface Non Engaging H 7.0 for Conical Abutment EVCAITMIC2025-12-10
08056591028284JDentalCare Conical AbutmentsInterface Engaging H 7.0 for Conical Abutment MINIEVCAITMIEC2025-12-10

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