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RealGUIDE IMPLANT MOUNT
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3DMUS00606MEGAOModel STRMINSESTR-1, STRMINSESTR-2, STRMINSESTR-3Ref 3DMUS00606ZIM31Ref 3DMUS00606INKRef 3DMUS00606EEXTRef 3DMUS00606XVE34Ref 3DMUS00606ZIM35Ref 3DMUS00606DENTRef 3DMUS00606MEGAR
by 3diemme Srl
Identity
- Trade Name
- IMPLANT MOUNT EUDAMEDRealGUIDE IMPLANT MOUNT FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- Surgical instruments for dental implantology - Tools Inserting/Extracting EUDAMEDImplant mount (Zimmer TSV D4,7mm connection) - RealGUIDE Z3D Kit FDA UDI
- Model / Reference
- STRMINSESTR-1, STRMINSESTR-2, STRMINSESTR-3 EUDAMED3DMUS00606MEGAO EUDAMED3DMUS00606ZIM31 EUDAMED3DMUS00606INK EUDAMED3DMUS00606EEXT EUDAMED3DMUS00606XVE34 EUDAMED3DMUS00606ZIM35 EUDAMED3DMUS00606DENT EUDAMED3DMUS00606MEGAR EUDAMED3DM00606ZIM47US FDA UDI
- Description
- Implant mount (Zimmer TSV D4,7mm connection) - RealGUIDE Z3D Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050038834292 EUDAMED08050038834209 EUDAMED08050038834285 EUDAMED08050038834261 EUDAMED08050038834384 EUDAMED08050038834216 EUDAMED08050038834254 EUDAMED08050038834308 EUDAMED08050038831116 FDA UDI
- Basic UDI-DI
- 805003883STRMINSESTRTC EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant holding endpiece, reusable
RealGUIDE IMPLANT MOUNT by 3diemme Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3diemme Srl
Sources (9)
- FDA UDI 8876fe62-4d7c-4664-843d-72e4126a2839 33 fields · synced Oct 7, 2026
- EUDAMED f6a49e58-3ce0-4979-8454-4d3f0a05227d 61 fields · synced Jun 20, 2026
- EUDAMED c1d91e0a-197c-4aa9-9732-2ff95136cef6 61 fields · synced Jul 8, 2026
- EUDAMED 24f00bb5-6585-4b1d-ba45-190e4906429b 61 fields · synced Jul 11, 2026
- EUDAMED 2274b1da-d413-4cd4-8ddb-a82013bda125 61 fields · synced Jul 11, 2026
- EUDAMED c421973b-e8f9-46a8-961e-6c1b1dcc5ec1 61 fields · synced Jul 19, 2026
- EUDAMED 14abdb84-9c11-46cd-a72d-bde73f850a55 61 fields · synced Jul 22, 2026
- EUDAMED 07f1c8a9-1fc3-4808-af0f-163c2bb85d00 61 fields · synced Jul 30, 2026
- EUDAMED 21411e9d-2fc9-461f-8aed-4cf46a72c8b0 61 fields · synced Sep 18, 2026