Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
FDA 510(k) K212475 · Prevest Denpro Limited
510(k) numberK212475
Submission
- Device name
- Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
- Applicant
- Prevest Denpro Limited
Bari Brahmana, IN - Received
- August 6, 2021
- Decision date
- May 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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 |
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| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…KIF · Traditional | 05/23/2022SE |
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Questions and answers
When was Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) cleared by the FDA?
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (K212475) received a 510(k) decision of Substantially Equivalent on May 13, 2022, 280 days after the submission was received.
What is the product code of K212475?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.