Parkell Desensitizer Gel
FDA 510(k) K191103 · Parkell, Inc.
510(k) numberK191103
Submission
- Device name
- Parkell Desensitizer Gel
- Applicant
- Parkell, Inc.
Edgewood, NY, US - Received
- April 25, 2019
- Decision date
- November 22, 2019
- 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 |
| 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 |
| 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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| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
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Questions and answers
When was Parkell Desensitizer Gel cleared by the FDA?
Parkell Desensitizer Gel (K191103) received a 510(k) decision of Substantially Equivalent on November 22, 2019, 211 days after the submission was received.
What is the product code of K191103?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.