Calcipulpe
FDA 510(k) K760659 · Septodont, Inc.
510(k) numberK760659
Submission
- Device name
- Calcipulpe
- Applicant
- Septodont, Inc.
Mchenry, IL, US - Received
- September 15, 1976
- Decision date
- September 27, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2gKIF · Traditional | 09/16/2021SE |
| K211799 | Biodentine XP 500, Biodentine XP 200KIF · Traditional | 08/10/2021SE |
| K172839 | EndosolvKIF · Traditional | 02/13/2018SE |
| K140132 | BiodentineKIF · Traditional | 06/27/2014SE |
| K093711 | RacegelMVL · Traditional | 02/17/2010SE |
| K092251 | BiodentineKIF · Traditional | 10/30/2009SE |
| K063634 | RTR SyringeLYC · Abbreviated | 05/11/2007SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | 05/02/2005SE |
| K032708 | Plastalgin and Plastalgin OrthoELW · Traditional | 11/20/2003SE |
| K780003 | Endosolv EKJJ · Traditional | 01/20/1978SE |
Questions and answers
When was Calcipulpe cleared by the FDA?
Calcipulpe (K760659) received a 510(k) decision of Substantially Equivalent on September 27, 1976, 12 days after the submission was received.
What is the product code of K760659?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.