The following data is part of a premarket notification filed by Silicon-und Composite Spezialitaten Gmbh with the FDA for Etching Gel.
| Device ID | K991450 |
| 510k Number | K991450 |
| Device Name: | ETCHING GEL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SILICON-UND COMPOSITE SPEZIALITATEN GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht SILICON-UND COMPOSITE SPEZIALITATEN GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| 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 | 1999-07-09 |
| Summary: | summary |