BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)

Implant, Endosseous, Root-form

BIOHORIZONS IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Dental Implant System (name Subject To Change).

Pre-market Notification Details

• Device ID: K964330
• 510k Number: K964330
• Device Name: BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
• Classification: Implant, Endosseous, Root-form
• Applicant: BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209
• Contact: R. Steven Boggan
• Correspondent: R. Steven Boggan; BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-31
• Decision Date: 1997-01-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847236001902	K964330	000