The following data is part of a premarket notification filed by Sterngold Dental Llc. with the FDA for Sternic Implant 4.2mm Rn, 1.8mm, 8.0mm / 4.1mm Rn, 1.8mm, 10.mm / 4.1 Mm Rn, 1.8mm, 12.0mm / 4.1mm Rn, 1.8mm, 14.0mm ....
Device ID | K111798 |
510k Number | K111798 |
Device Name: | STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... |
Classification | Implant, Endosseous, Root-form |
Applicant | STERNGOLD DENTAL LLC. 23 FRANK MOSSBERG DR Attleboro, MA 02703 |
Contact | Maria Rao |
Correspondent | Maria Rao STERNGOLD DENTAL LLC. 23 FRANK MOSSBERG DR Attleboro, MA 02703 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-27 |
Decision Date | 2012-06-01 |
Summary: | summary |