Neodent 127.028
by JJGC Indústria e Comércio de Materiais Dentários S/A.
Ref 127.028Model Instrument
Neodent 127.028 is a Class I device made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800065VT) and listed in FDA GUDID since 13 Dec 2022 (UDI-DI 07899878010784), active as of 23 Oct 2026.
Active
CE MDR
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 | Number987800065VT 07899878010784 | Date8 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07899878010784 | Date13 Dec 2022 | StatusListed |
Official records
- EUDAMED public site 987800065VT
- AccessGUDID record 07899878010784
Across registries
- EUDAMED Basic UDI-DI 987800065VT registered 8 May 2026 Active
- FDA GUDID UDI-DI 07899878010784 listed 13 Dec 2022 Listed
Timeline
- Listed FDA GUDID 07899878010784
- Registered EUDAMED 987800065VT
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Neodent
- Generic name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable
- Device name
- Dental Extractors
- Model / Ref / Catalog
- 127.028, Instrument
- Primary DI / UDI-DI
- 07899878010784
- Basic UDI-DI
- 987800065VT
- FDA product code
- DZN
- EMDN code
- T0202 Surgical procedural kits (excluding surgical instrument kits)
- GMDN term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable
- Device class
- Class I
- Regulation number
- 872.4565
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 2.1 MillimeterHeight — 10 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 07899878010784: EUDAMED states Yes, FDA GUDID states No.
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