The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Improved Dycal.
| Device ID | K780384 |
| 510k Number | K780384 |
| Device Name: | IMPROVED DYCAL |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | L.D. CAULK CO. 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 | 1978-03-09 |
| Decision Date | 1978-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D002623451Y1 | K780384 | 000 |
| D00262380262 | K780384 | 000 |
| D0026234001 | K780384 | 000 |
| D0026234501 | K780384 | 000 |
| D0026237011 | K780384 | 000 |
| D0026237021 | K780384 | 000 |
| D002611055011 | K780384 | 000 |
| D002611056061 | K780384 | 000 |
| D002611065011 | K780384 | 000 |
| D002611066061 | K780384 | 000 |
| D002623401Y1 | K780384 | 000 |
| D00262380162 | K780384 | 000 |