Bright Cavity Liner
FDA 510(k) K253248 · Dmp Dental Industry S.A.
510(k) numberK253248
Submission
- Device name
- Bright Cavity Liner
- Applicant
- Dmp Dental Industry S.A.
Markopoulo, GR - Received
- September 29, 2025
- Decision date
- January 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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
Questions and answers
When was Bright Cavity Liner cleared by the FDA?
Bright Cavity Liner (K253248) received a 510(k) decision of Substantially Equivalent on January 13, 2026, 106 days after the submission was received.
What is the product code of K253248?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.