The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Sinfony Dentin, Opaque-dentin, Enamel, Enamel Modifier, Transparent Opal,sinfony Magic Modifiers, Sinfony Opaquer.
| Device ID | K973513 |
| 510k Number | K973513 |
| Device Name: | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Contact | Barbara Wagner-schuh |
| Correspondent | Barbara Wagner-schuh ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-17 |
| Decision Date | 1997-12-22 |
| Summary: | summary |