The following data is part of a premarket notification filed by Sterngold Dental Llc with the FDA for Sfi-bar Implant Abutments.
Device ID | K132814 |
510k Number | K132814 |
Device Name: | SFI-BAR IMPLANT ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | STERNGOLD DENTAL LLC 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 -0967 |
Contact | Maria Rao |
Correspondent | Maria Rao STERNGOLD DENTAL LLC 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 -0967 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-09 |
Decision Date | 2014-02-25 |
Summary: | summary |