STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT

Implant, Endosseous, Root-form

APM STERN GOLD

The following data is part of a premarket notification filed by Apm Stern Gold with the FDA for Stern Era Alignment Correction Implant Abutment.

Pre-market Notification Details

• Device ID: K921010
• 510k Number: K921010
• Device Name: STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT
• Classification: Implant, Endosseous, Root-form
• Applicant: APM STERN GOLD 45 WEST ST. SUITE 2 Attleboro, MA 02703
• Contact: Lynne Aronson
• Correspondent: Lynne Aronson; APM STERN GOLD 45 WEST ST. SUITE 2 Attleboro, MA 02703
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-03
• Decision Date: 1992-09-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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