Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- TITAMAX IMPLANT EUDAMEDGM TITAMAX IMPLANT FDA UDI
- Model / Reference
- 109.899 EUDAMEDFDA UDIIMPLANT EUDAMED
- Description
- GM TITAMAX IMPLANT FDA UDI
Identifiers
- Catalog Number
- 109.899 FDA UDI
- Primary DI / UDI-DI
- 07899878023883 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800074VU EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 7 Millimeter FDA UDIOuter Diameter — 3.75 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 2b8beb54-a8cf-4f21-8ea5-4c4db69d9c2c 37 fields · synced Oct 6, 2026
- EUDAMED ef8da79e-a41e-479a-a6c7-bc672d99c921 61 fields · synced Jul 12, 2026