Obturys
510(k) K170207
Obturys is a medical device (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Itena Clinical, cleared under FDA 510(k) K170207 on 31 Jul 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170207 | Date31 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K170207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170207
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BJM Root Canal Sealer 400200 | 400200 | 07290115050523 | Total Volume 5 mL | On the market |
| OBTURYS Automix | ECHOBYS / Automix | 03760260221214 | On the market | |
| OBTURYS Automix | OBAX1-5 / Automix | 03760260221092 | On the market | |
| OBTURYS Handmix | OBHM1-5 / Handmix | 03760260221085 | On the market |
Similar devices
Other devices filed under FDA product code KIF (Resin, Root Canal Filling).
- MTA MATERIAL by Dentsply Intl.
- BioRoot Flow 0.5g, BioRoot Flow 2g by Septodont
- DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S by Drfp, Ltd.
- ADSEAL Plus Resin Root Canal Filling by Meta Biomed Co., Ltd.
- DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S by Drfp, Ltd.
- ROOT CANAL FILLING RESIN by Dentsply Intl.
- Well-Root ST by VERICOM CO., LTD.
- MTA vpt 1645 by VOCO GmbH
- Bio-C Sealer Ion+ by Angelus Industria de Produtos Odontologicos S A
- VioSeal Resin Root Canal Filling by Spident Co., Ltd.