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 |