2014 InterActive/SwishActive System

Implant, Endosseous, Root-form

Implant Direct Sybron Manufacturing LLC

The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for 2014 Interactive/swishactive System.

Pre-market Notification Details

• Device ID: K143011
• 510k Number: K143011
• Device Name: 2014 InterActive/SwishActive System
• Classification: Implant, Endosseous, Root-form
• Applicant: Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
• Contact: Debleena Sinha
• Correspondent: Debleena Sinha; Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-20
• Decision Date: 2015-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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