TRU Dental Implant System

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 Tru Dental Implant System.

Pre-market Notification Details

• Device ID: K150968
• 510k Number: K150968
• Device Name: TRU Dental Implant System
• Classification: Implant, Endosseous, Root-form
• 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: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-13
• Decision Date: 2015-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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