The following data is part of a premarket notification filed by Septodont, Inc. with the FDA for Calcipulpe.
| Device ID | K760659 |
| 510k Number | K760659 |
| Device Name: | CALCIPULPE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | SEPTODONT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-15 |
| Decision Date | 1976-09-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CALCIPULPE 73230576 1179749 Dead/Cancelled |
Mantel, widow of Mr. Schiller; Anny 1979-09-10 |