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 ...

Implant, Endosseous, Root-form

STERNGOLD DENTAL LLC.

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 ....

Pre-market Notification Details

Device IDK111798
510k NumberK111798
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 ...
ClassificationImplant, Endosseous, Root-form
Applicant STERNGOLD DENTAL LLC. 23 FRANK MOSSBERG DR Attleboro,  MA  02703
ContactMaria Rao
CorrespondentMaria Rao
STERNGOLD DENTAL LLC. 23 FRANK MOSSBERG DR Attleboro,  MA  02703
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-27
Decision Date2012-06-01
Summary:summary

NIH GUDID Devices

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