FDA.reportPublic FDA data

NA

Primary DI
07290118176589
Brand
NA
Company
UNIQA DENTAL LTD
Model
UIDR-3415
Catalog number
UIDR-3415
Device description
Ratchet screw driver for implants 2.42mm H15
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118176589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118176589072901181765897290118176589

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532098872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112853103NAUSTD-0004USTD-00042026-07-19
07290112854148NAUMSD-T604UMSD-T6042026-07-19
07290112854407NAUMSD-0002UUMSD-0002U2026-07-19
07290112854414NAUMSD-T604UUMSD-T604U2026-07-19
07290112855138NAUTBV-0015UTBV-00152026-07-19
07290112855145NAUTBV-0003UTBV-00032026-07-19
07290112855152NAUTBV-0004UTBV-00042026-07-19
07290112855169NAUTBV-0006UTBV-00062026-07-19
07290112855749NAUMSD-0003UMSD-00032026-07-19
07290112855756NAUMSD-0003UUMSD-0003U2026-07-19
07290112855763NAUMSD-T603UMSD-T6032026-07-19
07290112855770NAUMSD-T603UUMSD-T603U2026-07-19
07290112856692NAUMSD-0005UMSD-00052026-07-19
07290112857637NAUTBV-0008UTBV-00082026-07-19
07290118030003NAUSTD-0004CUSTD-0004C2026-07-19
07290118030010NAUSTD-0003CUSTD-0003C2026-07-19
07290118177333NAUSTD-0006USTD-00062026-07-19
07290118177340NAUSTD-0006CUSTD-0006C2026-07-19
07290118177357NAUSTD-T603USTD-T6032026-07-19
07290118177364NAUSTD-T603CUSTD-T603C2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12