The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Reprosil.
| Device ID | K781151 |
| 510k Number | K781151 |
| Device Name: | REPROSIL |
| Classification | Material, Impression |
| Applicant | DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-10 |
| Decision Date | 1978-08-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REPROSIL 73193203 1128509 Live/Registered |
DENTSPLY INTERNATIONAL INC. 1978-11-13 |