OMNI-TIGHT

Implant, Endosseous, Root-form

BASIC DENTAL IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Basic Dental Implant Systems, Inc. with the FDA for Omni-tight.

Pre-market Notification Details

• Device ID: K072595
• 510k Number: K072595
• Device Name: OMNI-TIGHT
• Classification: Implant, Endosseous, Root-form
• Applicant: BASIC DENTAL IMPLANT SYSTEMS, INC. 535 ZANG STREET SUITE 100 Lakewood, CO 80228
• Contact: Rich Weiskopf
• Correspondent: Rich Weiskopf; BASIC DENTAL IMPLANT SYSTEMS, INC. 535 ZANG STREET SUITE 100 Lakewood, CO 80228
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-14
• Decision Date: 2008-05-09
• Summary: summary