FDA Registration
Active
🇮🇹 Italy
3DIEMME SRL
Reg #: 3015173183
·
FEI: 3015173183
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- 3DIEMME SRL
- Registration Number
- 3015173183
- FEI Number
- 3015173183
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Risorgimento 9
- City
- Cantu Como
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K173041
Owner / Operator
- Firm Name
- 3DIEMME Srl
- Operator Number
- 10059505
- Address
- Via Risorgimento 9
- City
- Cantu
- State
- Como
- Postal Code
- 22063
- Country
- IT
US Agent
- Business Name
- ZimVie US Corp LLC
- Contact Name
- Henrique Nomelini Muniz
- Address
- 4555 Riverside Dr
- City
- Palm Beach Gardens
- State
- FL
- ZIP
- 33410
- Country
- US
- [email protected]
- Phone
- 561 7766700
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-10-30 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-01-29 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2022-07-21 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-04-24 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2022-12-14 |
Proprietary Names
Universal RealGUIDE box
RealGuide Software Suite
AIS 3D app
DRILL BIT
BONE CREST LEVELER
TORQUE WRENCH EXTENSION
MOUTH OPENING GAUGE
RealGUIDE IMPLANT MOUNT
TISSUE PUNCH
SQUARE CONNECTOR FOR HANDPIECE
RealGUIDE SLEEVE
ANCHOR PINS
DRILL
EVOBITE
Establishment Types
Manufacture Medical Device