SPI SYSTEM DENTAL IMPLANTS

Implant, Endosseous, Root-form

THOMMEN MEDICAL, AG

The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi System Dental Implants.

Pre-market Notification Details

• Device ID: K072649
• 510k Number: K072649
• Device Name: SPI SYSTEM DENTAL IMPLANTS
• Classification: Implant, Endosseous, Root-form
• Applicant: THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130
• Contact: Linda K Schulz
• Correspondent: Linda K Schulz; THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-19
• Decision Date: 2007-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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