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
00841549101410	K921010	000
00841549101458	K921010	000
00841549101465	K921010	000
00841549102189	K921010	000
00841549102196	K921010	000
00841549102202	K921010	000
00841549102257	K921010	000
00841549102356	K921010	000
00841549102363	K921010	000
00841549102417	K921010	000
00841549102424	K921010	000
00841549101441	K921010	000
00841549103094	K921010	000
00841549103087	K921010	000
00841549101427	K921010	000
00841549101434	K921010	000
00841549102264	K921010	000
00841549102295	K921010	000
00841549102332	K921010	000
00841549102349	K921010	000
00841549102622	K921010	000
00841549103056	K921010	000
00841549103063	K921010	000
00841549103070	K921010	000
00841549102615	K921010	000
08415491040527	K921010	000
08415491043757	K921010	000
08415491044716	K921010	000
08415491044723	K921010	000
08415491052278	K921010	000
08415491052285	K921010	000
08415491052292	K921010	000
08415491151711	K921010	000
08415491151728	K921010	000
08415491151735	K921010	000
08415491151742	K921010	000
08415491043191	K921010	000
08415491043184	K921010	000
08415491043146	K921010	000
08415491040534	K921010	000
08415491040541	K921010	000
08415491040558	K921010	000
08415491040565	K921010	000
08415491040589	K921010	000
08415491043092	K921010	000
08415491043108	K921010	000
08415491043115	K921010	000
08415491043122	K921010	000
08415491043139	K921010	000
08415491151759	K921010	000