The following data is part of a premarket notification filed by Js Dental Mfg., Inc. with the FDA for Calasept Paste.
| Device ID | K895508 |
| 510k Number | K895508 |
| Device Name: | CALASEPT PASTE |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | JS DENTAL MFG., INC. P.O. BOX 904 Ridgefield, CT 06877 |
| Contact | Abraham Wohl |
| Correspondent | Abraham Wohl JS DENTAL MFG., INC. P.O. BOX 904 Ridgefield, CT 06877 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17310230000146 | K895508 | 000 |
| 17310230000078 | K895508 | 000 |
| 17310230000054 | K895508 | 000 |