The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for New Dentin Primer.
| Device ID | K930504 |
| 510k Number | K930504 |
| Device Name: | NEW DENTIN PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | Jeffery Lehn |
| Correspondent | Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1993-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026342550 | K930504 | 000 |
| D0026342450 | K930504 | 000 |
| D00263422751 | K930504 | 000 |