FDA.reportPublic FDA data

RealGUIDE Surgical Kit

Primary DI
08050038832021
Brand
RealGUIDE Surgical Kit
Company
3DIEMME SRL
Model
3DM00700US
Published
2025-08-07
Public version status
New
Distribution status
Not 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
08050038832021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038832021080500388320218050038832021

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
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
08050038831116RealGUIDE IMPLANT MOUNT3DM00606ZIM47US2022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07