MODIFICATION TO THE MAESTRO SYSTEM

Abutment, Implant, Dental, Endosseous

BIOHORIZONS IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Modification To The Maestro System.

Pre-market Notification Details

• Device ID: K022795
• 510k Number: K022795
• Device Name: MODIFICATION TO THE MAESTRO SYSTEM
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243
• Contact: Winston Greer
• Correspondent: Winston Greer; BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-08-23
• Decision Date: 2002-08-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847236002220	K022795	000
00847236001964	K022795	000
00847236002015	K022795	000
00847236002022	K022795	000
00847236002176	K022795	000
00847236002183	K022795	000
00847236002190	K022795	000
00847236002206	K022795	000
00847236002213	K022795	000
00847236001919	K022795	000