The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Hytac.
| Device ID | K992909 |
| 510k Number | K992909 |
| Device Name: | HYTAC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Andreas Peterman |
| Correspondent | Andreas Peterman ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, 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 | 1999-08-30 |
| Decision Date | 1999-11-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HYTAC 75796362 2408352 Live/Registered |
CMT Materials, Inc. 1999-09-10 |
![]() HYTAC 75194070 2134059 Dead/Cancelled |
THERA Patent GmbH & Co. KG Gesellschaftfur industrielle Schutzrechte 1996-11-06 |