The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Lava Frame, Lava Frame Shade.
Device ID | K072055 |
510k Number | K072055 |
Device Name: | LAVA FRAME, LAVA FRAME SHADE |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-26 |
Decision Date | 2008-02-26 |
Summary: | summary |