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Ditron Dental
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TBH-200640Model Wrench / Torque Ratchet
Identity
- Trade Name
- Wrench / Torque Ratchet EUDAMEDDitron Dental FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Ratchet Wrench hex 6.4 EUDAMEDTorque Ratchet Bending arm hex 6.4, 10-70 Ncm FDA UDI
- Model / Reference
- TBH-200640 EUDAMEDFDA UDIWrench / Torque Ratchet EUDAMED
- Description
- Torque Ratchet Bending arm hex 6.4, 10-70 Ncm FDA UDI
Identifiers
- Catalog Number
- TBH-200640 FDA UDI
- Primary DI / UDI-DI
- 07290109284392 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010928RATCEA EUDAMED
- Direct Marketing DI
- 07290109284392 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental torque wrench 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: Dental torque wrench
Ditron Dental by Ditron Dental Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental torque wrench.
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- Torque Wrench — Elos Medtech Pinol A/S · Class I
- Restore — Keystone Dental Inc. · Class I
- 4-Part Telescoping Herbst Replacement Parts — SPECIALTY APPLIANCES, LLC · Class I
- RS 2.45 Hex Handpiece Adapter FLX - Short — ADIN DENTAL IMPLANT SYSTEMS LTD · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- Graduated Torque Wrench — Sterngold Dental LLC · Class I
- SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · Class I
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 1a834bee-9ac7-4307-ba75-29559c5d4a1e 35 fields · synced Jun 18, 2026
- EUDAMED fc64bd7f-ff7d-4f2f-8bdc-439d8e46e2dd 61 fields · synced Jun 18, 2026