One-Fil LC
FDA 510(k) K261728 · Mediclus Co., Ltd.
510(k) numberK261728
Submission
- Device name
- One-Fil LC
- Applicant
- Mediclus Co., Ltd.
Cheongju-Si, KR - Received
- May 26, 2026
- Decision date
- July 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253248 | Bright Cavity LinerEJK · Traditional | Dmp Dental Industry S.A. | 01/13/2026SE |
| K230270 | 3M VitCal Liner/BaseEJK · Traditional | 3M Espe Dental Products | 02/06/2023SE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional | Prevest Denpro Limited | 05/13/2022SE |
| K201799 | CleaniCalEJK · Traditional | Maruchi | 02/12/2021SE |
| K202413 | LC ResinCal PCEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaten… | 11/20/2020SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | Parkell, Inc. | 11/22/2019SE |
| K180344 | TheraCal DCEJK · Special | Bisco, Inc. | 04/05/2018SE |
| K143292 | TheraCal DCEJK · Traditional | Bisco, Inc. | 08/04/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | Sybron Dental Specialties | 06/19/2015SE |
| K141047 | LC Calciumhydroxide LinerEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaeten | 04/14/2015SE |
More from S&C Polymer Silicon- Und Composite Spezialitaeten
| 510(k) | Device | Decision |
|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | 08/21/2026SE |
| K254201 | Any-CemEMA · Traditional | 08/13/2026SE |
| K260485 | Any-EtchKLE · Traditional | 05/14/2026SE |
| K260819 | Any-Com SealEBC · Traditional | 05/01/2026SE |
| K253797 | One-StopMVL · Traditional | 02/27/2026SE |
| K253167 | Any-PasteKIF · Traditional | 01/12/2026SE |
| K252465 | Any-CoreEBF · Traditional | 12/05/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | 08/22/2025SE |
| K251283 | Once-Fil FlowEBF · Traditional | 06/06/2025SE |
| K250823 | Any-Com FlowEBF · Special | 04/14/2025SE |
Questions and answers
When was One-Fil LC cleared by the FDA?
One-Fil LC (K261728) received a 510(k) decision of Substantially Equivalent on July 21, 2026, 56 days after the submission was received.
What is the product code of K261728?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.