BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS

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 Biohorizons Plastic Temporary Abutments.

Pre-market Notification Details

• Device ID: K053099
• 510k Number: K053099
• Device Name: BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-03
• Decision Date: 2006-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847236014681	K053099	000