The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Pre-impression Conditioning Solution.
| Device ID | K061427 |
| 510k Number | K061427 |
| Device Name: | PRE-IMPRESSION CONDITIONING SOLUTION |
| Classification | Material, Impression |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-23 |
| Decision Date | 2006-06-26 |
| Summary: | summary |