The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann P.004 Cementable Abutments, Temporary Copings And Protective Caps.
Device ID | K072071 |
510k Number | K072071 |
Device Name: | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
Contact | Elaine Alan |
Correspondent | Elaine Alan INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-30 |
Decision Date | 2007-08-15 |
Summary: | summary |