QUANTUM DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

QUANTUM BIOENGINEERING, LTD.

The following data is part of a premarket notification filed by Quantum Bioengineering, Ltd. with the FDA for Quantum Dental Implant System.

Pre-market Notification Details

• Device ID: K112279
• 510k Number: K112279
• Device Name: QUANTUM DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: QUANTUM BIOENGINEERING, LTD. 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130
• Contact: Linda Schulz
• Correspondent: Linda Schulz; QUANTUM BIOENGINEERING, LTD. 11234 EL CAMINO REAL, SUITE 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: 2011-08-09
• Decision Date: 2012-05-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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