Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental elevator, sinus lift FDA UDI
- Device Name
- Sinus Lift & Osteotomes EUDAMEDSINUS LIFT CURETTE N. 3 FDA UDI
- Model / Reference
- 126.009 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- SINUS LIFT CURETTE N. 3 FDA UDI
Identifiers
- Catalog Number
- 126.009 FDA UDI
- Primary DI / UDI-DI
- 07899878010623 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800061VK EUDAMED
- FDA Product Code
- EMK FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental elevator, sinus lift FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
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
Category: Dental elevator, sinus lift
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
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 8d200a11-10ae-4075-9675-ac196d9058be 36 fields · synced Aug 1, 2026
- EUDAMED 0105eff6-d6ae-4843-81da-2a680aa57f3c 61 fields · synced Aug 1, 2026