Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental torque wrench adaptor FDA UDI
- Device Name
- Drilling Instruments EUDAMEDTORQUE WRENCH ADAPTOR CONNECTIONS CONTRA ANGLE FDA UDI
- Model / Reference
- 105.025 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- TORQUE WRENCH ADAPTOR CONNECTIONS CONTRA ANGLE FDA UDI
Identifiers
- Catalog Number
- 105.025 FDA UDI
- Primary DI / UDI-DI
- 07898237563923 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800134VM EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Dental torque wrench adaptor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 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
No
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
Category: Dental torque wrench adaptor
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Inclusive — PRISMATIK DENTALCRAFT, INC. · 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
Sources (2)
- FDA UDI 53579be8-c78d-4e3a-b3b6-c68037739821 36 fields · synced Jul 10, 2026
- EUDAMED fde08b9e-8601-4140-a324-59be32a7e8a9 61 fields · synced Jul 10, 2026