FDA.reportPublic FDA data

RealGUIDE Surgical Instruments

Primary DI
08050038833462
Brand
RealGUIDE Surgical Instruments
Company
3DIEMME SRL
Model
STRMTAGL-1
Catalog number
3DMUS00613.28.080Z
Device description
DOUBLE D. DRILL D2.8/2.4X8 mm
Published
2026-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08050038833462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038833462080500388334628050038833462

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
441467351
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038833172RealGUIDEREALGUIDE WIN2026-08-31
08050038833189RealGUIDEREALGUIDE MAC2026-08-31
08050038833196RealGUIDEREALGUIDE WEB2026-08-31
08050038833264RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS006212026-06-29
08050038833271RealGUIDE Surgical InstrumentsSTRMTAGL-63DMUS006102026-06-30
08050038833288RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.0702026-06-29
08050038833295RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.1152026-06-29
08050038833301RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.16.1502026-06-29
08050038833318RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.21.1502026-06-29
08050038833325RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.0852026-06-29
08050038833332RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1002026-06-29
08050038833349RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1152026-06-29
08050038833356RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1302026-06-29
08050038833394RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.23.1602026-06-29
08050038833400RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.080Z2026-06-29
08050038833417RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.100Z2026-06-29
08050038833424RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.115Z2026-06-29
08050038833431RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.130Z2026-06-29
08050038833448RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.1502026-06-29
08050038833455RealGUIDE Surgical InstrumentsSTRMTAGL-13DMUS00613.24.160Z2026-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076476356TruBite ScopeTruabutment Korea Co.,LtdNDP2026-11-03
08800076476486TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476493TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476509TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476516TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
07290109308654Single TMA Snap-On TransferADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770383IRIS™, Burnout anti rotation cap red (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07640169734823BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736056BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736063BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736070BiodentaBiodenta Swiss AGNDP2026-10-30
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234384HELICAL DRILL Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234636GUIDED INITIAL DRILL Ø2.0X5MMSin Sistema de Implante Nacional S/ANDP2026-10-30
08050038833271RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833745RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833752RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833769RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833776RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30