MTA2.3 MATERIALS
FDA 510(k) clearance K181917 · decided 2019-01-11
Clearance details
- K-number
- K181917
- Device name
- MTA2.3 MATERIALS
- Applicant
- NuSmile, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-17
- Decision date
- 2019-01-11
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- KIF
- Device class
- 2
- Regulation number
- 872.3820
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Injectable Root Canal Sealer (KP-Root SP) (K261415) | Guilin Kevin Peter Technology Co., Ltd. | 2026-06-29 |
| Any-Paste (K253167) | Mediclus Co., Ltd. | 2026-01-12 |
| ZenSeal Pro (K252890) | Kerr Corporation | 2026-01-07 |
| Root canal repair materials (nRoot BP) (K251465) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 |
| Well-Root PT (K252285) | Vericom Co., Ltd. | 2025-09-19 |
| One-Fil Putty Injectable (K251884) | Mediclus Co., Ltd. | 2025-08-22 |
| MTA vpt (K251390) | Voco GmbH | 2025-07-03 |
| Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710) | Enpuno Co., Ltd. | 2025-06-11 |
| One-Fil Putty (K243353) | Mediclus Co., Ltd. | 2025-03-14 |
| AH Plus Endodontic Sealer (K243546) | Dentsply Sirona, Inc. | 2025-02-13 |
| Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (K242934) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 |
| VioSeal (K242702) | Spident Co., Ltd. | 2024-11-07 |
Recalls involving this device
No recalls on record reference this clearance.