The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Caulk Tooth Conditioner Gel And Syringe.
| Device ID | K942031 |
| 510k Number | K942031 |
| Device Name: | CAULK TOOTH CONDITIONER GEL AND SYRINGE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | P. Jeffrey Lehn |
| Correspondent | P. Jeffrey Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1994-06-10 |