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 |