Neodent 105.139
by JJGC Indústria e Comércio de Materiais Dentários S/A.
Part of a family of 56 devices: see the family page
Ref 105.139Model Instrument
Neodent 105.139 is a device classified as Class IIa in the EU and Class I in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800081VR) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 07899878029939), active as of 23 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number987800081VR 07899878029939 | Date8 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07899878029939 | Date12 Dec 2022 | StatusListed |
Official records
- EUDAMED public site 987800081VR
- AccessGUDID record 07899878029939
Across registries
- EUDAMED Basic UDI-DI 987800081VR registered 8 May 2026 Active
- FDA GUDID UDI-DI 07899878029939 listed 12 Dec 2022 Listed
Timeline
- Listed FDA GUDID 07899878029939
- Registered EUDAMED 987800081VR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Neodent
- Generic name
- Dental implant system
- Device name
- Connectors and Drivers for Contra-Angle
- Model / Ref / Catalog
- 105.139, Instrument
- Primary DI / UDI-DI
- 07899878029939
- Basic UDI-DI
- 987800081VR
- FDA product code
- EIF
- EMDN code
- L99 Surgical instruments, reusable - other
- GMDN term
- Dental implant system
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 872.4565
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
| Sterilise before use | Yes | No |
| Implantable | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 07899878029939: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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