The following data is part of a premarket notification filed by Institut Straumann Sa with the FDA for Rn Synocta Temporary Meso Abutment.
Device ID | K051717 |
510k Number | K051717 |
Device Name: | RN SYNOCTA TEMPORARY MESO ABUTMENT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | INSTITUT STRAUMANN SA 60 MINUTEMAN ROAD Andover, MA 01810 |
Contact | Linda Jalbert |
Correspondent | Linda Jalbert INSTITUT STRAUMANN SA 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 | 2005-06-27 |
Decision Date | 2005-07-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630031725677 | K051717 | 000 |