D/Sense 1-STEP
FDA 510(k) K021146 · Centrix, Inc.
510(k) numberK021146
Submission
- Device name
- D/Sense 1-STEP
- Applicant
- Centrix, Inc.
Shelton, CT, US - Received
- April 9, 2002
- Decision date
- July 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJK
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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 |
| 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 |
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| K152826 | NoCordELW · Traditional | 05/27/2016SE |
| K140144 | Benda WedgeEJB · Traditional | 07/08/2014SE |
| K120176 | Senzzzzz AwayLBH · Traditional | 07/25/2012SE |
| K111348 | Re / Stasis (TM) Gingival Retraction PasteMVL · Traditional | 07/22/2011SE |
| K092384 | LiquicordMVL · Traditional | 11/04/2009SE |
| K091380 | CordcapMVL · Traditional | 07/30/2009SE |
| K021131 | ChloraprepLBH · Traditional | 09/26/2002SE |
Questions and answers
When was D/Sense 1-STEP cleared by the FDA?
D/Sense 1-STEP (K021146) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 84 days after the submission was received.
What is the product code of K021146?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.