Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental implant internal thread shaping tool FDA UDI
- Device Name
- Instruments for Rescue Kit EUDAMEDRECTIFIER SET1.8 mm FDA UDI
- Model / Reference
- 130.079 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- RECTIFIER SET1.8 mm FDA UDI
Identifiers
- Catalog Number
- 130.079 FDA UDI
- Primary DI / UDI-DI
- 07899878031802 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800044VK EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant internal thread shaping tool 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
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 implant internal thread shaping tool
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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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
Sources (2)
- FDA UDI 71be609b-24b0-4a66-b0b3-ba5332b6cc9e 36 fields · synced Jun 18, 2026
- EUDAMED debe566f-4476-4590-a622-0d35dc32a70b 61 fields · synced Jun 18, 2026