← Back to catalogue
Double diameter drill D2, 8/2, 4x10mm RealGUIDE Z3D Kit
FDA UDIClass I (US FDA UDI)
by 3diemme Srl
Identity
- Trade Name
- Double diameter drill D2,8/2,4x10mm RealGUIDE Z3D Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- 3DM00613.28.100ZUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050038831390 FDA UDI
- FDA Product Code
- QRQ FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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/maxillofacial surgical procedure kit, non-medicated, reusable
Double diameter drill D2, 8/2, 4x10mm RealGUIDE Z3D Kit by 3diemme Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3diemme Srl
Sources (1)
- FDA UDI d6a5fa95-9458-4f23-b9d6-27e92c351419 32 fields · synced May 30, 2026