The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Lc Microfill.
Device ID | K991442 |
510k Number | K991442 |
Device Name: | LC MICROFILL |
Classification | Material, Tooth Shade, Resin |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
Contact | Jurgen Engelbrecht |
Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-26 |
Decision Date | 1999-06-03 |
Summary: | summary |