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Ditron Dental
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TMAL-200280Model Prosthetic Screwdrivers
Identity
- Trade Name
- Prosthetic Screwdrivers EUDAMEDDitron Dental FDA UDI
- Generic Name
- Screwing power tool attachment FDA UDI
- Device Name
- Angulated Prosthetic Screwdriver, WL15mm L27mm EUDAMEDLong Motor Adaptor for 1.25mm FDA UDI
- Model / Reference
- TMAL-200280 EUDAMEDFDA UDIProsthetic Screwdrivers EUDAMED
- Description
- Long Motor Adaptor for 1.25mm FDA UDI
Identifiers
- Catalog Number
- TMAL-200280 FDA UDI
- Primary DI / UDI-DI
- 07290109285719 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010928DRIVE2 EUDAMED
- Direct Marketing DI
- 07290109285719 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Screwing power tool attachment 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Screwing power tool attachment
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
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
- Ditron Dental Ltd
Sources (2)
- FDA UDI b2c7c5f4-4172-44ce-9f53-7b5f605d0245 35 fields · synced Jun 11, 2026
- EUDAMED d98997aa-036b-47d1-9396-f2a8e7d2225f 61 fields · synced Jun 11, 2026