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: K082749
• 510k Number: K082749
• Device Name: OMNI-TIGHT
• Classification: Implant, Endosseous, Root-form
• Applicant: BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA N.E. Albuquerque, NM 87107 -2001
• Contact: Dan Blacklock
• Correspondent: Dan Blacklock; BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA N.E. Albuquerque, NM 87107 -2001
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-19
• Decision Date: 2008-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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