Odontit INORG-4
by Odontit S.A.
Odontit INORG-4 is a screw endosteal dental implant (FDA Class II; FDA product code DZE, Implant, Endosseous, Root-Form) made by Odontit S.A., listed in FDA GUDID since 29 May 2019 (UDI-DI D914INORG40), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD914INORG40 | Date29 May 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Odontit
- Generic name
- Screw endosteal dental implant, two-piece
- Model / Ref / Catalog
- INORG-4
- Primary DI / UDI-DI
- D914INORG40
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, two-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Screw endosteal dental implant, two-piece.
- s-Clean SAVE Fixture DSFS6007 by DENTIS CO., LTD
- SuperLine II FXS4012C by DENTIUM USA
- i-Clean OneQ-SL Fixture DISOF4847123 by DENTIS CO., LTD
- Tuff PRO Implant NMAF3710 by NORIS MEDICAL LTD
- ST STR3513SSF by Shinhung MST Co., Ltd.
- Zygomatic Implant NM-F4437 by NORIS MEDICAL LTD
- ST STR4013LSF by Shinhung MST Co., Ltd.
- SuperLine FX3612SWC by DENTIUM USA
- Z5-BL-5010 by Z-Systems AG