Ditron Dental
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Insertion Drivers EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Angulated Prosthetic Screwdriver, WL15mm L27mm EUDAMEDImplant Long Hand Driver Internal Hex 6.35 mm FDA UDI
- Model / Reference
- RHD-635 EUDAMEDFDA UDIProsthetic Screwdrivers EUDAMED
- Description
- Implant Long Hand Driver Internal Hex 6.35 mm FDA UDI
Identifiers
- Catalog Number
- RHD-635 FDA UDI
- Primary DI / UDI-DI
- 07290109284354 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010928DRIVE2 EUDAMED
- Direct Marketing DI
- 07290109284354 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Ditron Dental by Ditron Dental Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Ditron Dental Ltd
Sources (2)
- FDA UDI 382914ec-b868-4676-9657-0e374967932f 35 fields · synced Jul 9, 2026
- EUDAMED 6657e89b-6780-475d-b3ce-7fc52210291e 61 fields · synced Jul 9, 2026