The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Glass Ceramics.
| Device ID | K053438 |
| 510k Number | K053438 |
| Device Name: | GLASS CERAMICS |
| Classification | Powder, Porcelain |
| Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Sabine Krischer |
| Correspondent | Sabine Krischer 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-01-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLASS CERAMICS 74670961 not registered Dead/Abandoned |
TRIDENT DENTAL LABORATORIES 1995-05-08 |