SWISSPLANT DENTAL IMPLANT SYSTEM

Abutment, Implant, Dental, Endosseous

IMPLANT DIRECT LLC

The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Swissplant Dental Implant System.

Pre-market Notification Details

• Device ID: K081396
• 510k Number: K081396
• Device Name: SWISSPLANT DENTAL IMPLANT SYSTEM
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301
• Contact: Thomas Gottenbos
• Correspondent: Thomas Gottenbos; IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-05-19
• Decision Date: 2009-01-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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