The following data is part of a premarket notification filed by Sterngold Dental, Llc with the FDA for Straight Stud Attachment.
Device ID | K142407 |
510k Number | K142407 |
Device Name: | Straight Stud Attachment |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703 |
Contact | Maria Rao |
Correspondent | Maria Rao Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-28 |
Decision Date | 2014-12-24 |
Summary: | summary |