The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Cerec Blocs C In.
Device ID | K123952 |
510k Number | K123952 |
Device Name: | CEREC BLOCS C IN |
Classification | Powder, Porcelain |
Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
Contact | Fritz Kolle |
Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-21 |
Decision Date | 2013-03-20 |
Summary: | summary |