Theracal LC
FDA 510(k) K063237 · Bisco, Inc.
510(k) numberK063237
Submission
- Device name
- Theracal LC
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- October 26, 2006
- Decision date
- December 8, 2006
- 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 |
| 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 |
More from Sybron Dental Specialties
| 510(k) | Device | Decision |
|---|---|---|
| K250156 | Choice 2 DCEMA · Traditional | 07/11/2025SE |
| K242816 | QuantiumEBF · Traditional | 12/17/2024SE |
| K192007 | TheraBase, TheraBase CaEMA · Traditional | 03/17/2020SE |
| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
| K161256 | TheraCemEMA · Traditional | 07/29/2016SE |
Questions and answers
When was Theracal LC cleared by the FDA?
Theracal LC (K063237) received a 510(k) decision of Substantially Equivalent on December 8, 2006, 43 days after the submission was received.
What is the product code of K063237?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.