CleaniCal
FDA 510(k) K201799 · Maruchi
510(k) numberK201799
Submission
- Device name
- CleaniCal
- Applicant
- Maruchi
Wonju-Si, KR - Received
- June 30, 2020
- Decision date
- February 12, 2021
- 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 |
|---|---|---|---|
| K261728 | One-Fil LCEJK · Traditional | Mediclus Co., Ltd. | 07/21/2026SE |
| 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 |
| 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 |
|---|---|---|
| K213757 | Endocem MTA Premixed RegularKIF · Traditional | 02/14/2023SE |
| K212229 | White Endoseal MTAKIF · Special | 08/13/2021SE |
| K202015 | White ENDOSEAL MTAKIF · Traditional | 03/24/2021SE |
| K170175 | Endoseal MtaKIF · Traditional | 02/26/2018SE |
| K133054 | EndosealKIF · Traditional | 05/12/2014SE |
| K133042 | Endocem ZRKIF · Traditional | 05/12/2014SE |
| K112078 | Endocem Mta (Mineral Trioxide Aggregate)KIF · Traditional | 03/19/2012SE |
Questions and answers
When was CleaniCal cleared by the FDA?
CleaniCal (K201799) received a 510(k) decision of Substantially Equivalent on February 12, 2021, 227 days after the submission was received.
What is the product code of K201799?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.