The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Caulk Dycal Light Cured.
| Device ID | K850641 |
| 510k Number | K850641 |
| Device Name: | CAULK DYCAL LIGHT CURED |
| Classification | Coating, Filling Material, Resin |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | John O Semmelman |
| Correspondent | John O Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-18 |