BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM

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 Laser-lok 3.0 Implant System.

Pre-market Notification Details

• Device ID: K093321
• 510k Number: K093321
• Device Name: BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244
• Contact: Michael Davis
• Correspondent: Michael Davis; BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-23
• Decision Date: 2010-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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