FDA.reportPublic FDA data

RealGUIDE Z3D Torque wrench extension

Primary DI
08050038831871
Brand
RealGUIDE Z3D Torque wrench extension
Company
3DIEMME SRL
Model
3DM00623ZUS
Published
2022-07-14
Public version status
Update
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
08050038831871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038831871080500388318718050038831871

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
857172105
Device count
1
Premarket exempt
true
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
08050038833226RealGUIDE Z3D KIT, Empty Tray 3DM00632ZUS2026-03-10
08050038834407RealGUIDE Z3D Surgical Kit3DM0070ZUS2026-03-10
18050038834411RealGUIDE Sleeve3DM00605AZTC40.102026-03-10
18050038834428RealGUIDE Sleeve3DM00605AZTC50.102026-03-10
18050038834435RealGUIDE Sleeve3DM00605AZTC60.102026-03-10
18050038834442RealGUIDE Sleeve3DM00605NEOEG.102026-03-10
18050038834459RealGUIDE Sleeve3DM00605NEOGM.102026-03-10
18050038834466RealGUIDE Sleeve3DM00605NEOGMNRW.102026-03-10
18050038834473RealGUIDE Sleeve3DM00605NEOGMWD.102026-03-10
18050038834541RealGUIDE Sleeve3DM00605NEOEGNRW.102026-03-10
18050038834558RealGUIDE Sleeve3DM00605CAMPL33.102026-03-10
18050038834565RealGUIDE Sleeve3DM00605CAMPL38.102026-03-10
18050038834572RealGUIDE Sleeve3DM00605CAMPL43.102026-03-10
18050038834589RealGUIDE Sleeve3DM00605CAMPL50.102026-03-10
18050038834596RealGUIDE Sleeve3DM00605STRSL.102026-03-10
08050038832021RealGUIDE Surgical Kit3DM00700US2025-08-07
08050038832144RealGUIDE™ Z3D KIT, Empty Tray 3DM00632ZUS2024-12-06
08050038833165AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY 3DM00632TBLTRAY2024-12-06
08050038831093RealGUIDE IMPLANT MOUNT3DM00606ZIM31US2022-07-01
08050038831109RealGUIDE IMPLANT MOUNT3DM00606ZIM35US2022-07-01

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Primary DI, Brand, Company table
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00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
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06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
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06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
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08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
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