STERN MICRO ERA ATTACHMENT SYSTEM

Implant, Endosseous, Root-form

STERNGOLD

The following data is part of a premarket notification filed by Sterngold with the FDA for Stern Micro Era Attachment System.

Pre-market Notification Details

• Device ID: K020391
• 510k Number: K020391
• Device Name: STERN MICRO ERA ATTACHMENT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967
• Contact: Maria Rao
• Correspondent: Maria Rao; STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-02-06
• Decision Date: 2002-03-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841549101021	K020391	000
00841549100642	K020391	000
00841549100659	K020391	000
00841549100666	K020391	000
00841549100673	K020391	000
00841549100680	K020391	000
00841549100697	K020391	000
00841549100703	K020391	000
00841549100710	K020391	000
00841549100727	K020391	000
00841549100635	K020391	000
00841549101335	K020391	000
00841549102660	K020391	000
00841549102691	K020391	000
00841549101212	K020391	000
00841549101229	K020391	000
00841549101236	K020391	000
00841549101243	K020391	000
00841549101250	K020391	000
00841549101267	K020391	000
00841549101328	K020391	000
00841549100734	K020391	000
00841549100741	K020391	000
00841549100758	K020391	000
00841549100871	K020391	000
00841549101045	K020391	000
08415491058836	K020391	000
08415491058843	K020391	000
08415491058850	K020391	000
08415491058867	K020391	000
08415491064363	K020391	000
08415491124715	K020391	000
08415491134264	K020391	000
00841549100864	K020391	000
00841549100857	K020391	000
00841549100765	K020391	000
00841549100772	K020391	000
00841549100789	K020391	000
00841549100796	K020391	000
00841549100802	K020391	000
00841549100819	K020391	000
00841549100826	K020391	000
00841549100833	K020391	000
00841549100840	K020391	000
08415491134271	K020391	000