NEODENT IMPLANT SYSTEM

Implant, Endosseous, Root-form

JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S

The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S with the FDA for Neodent Implant System.

Pre-market Notification Details

• Device ID: K123022
• 510k Number: K123022
• Device Name: NEODENT IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130
• Contact: Allison C Komiyama
• Correspondent: Allison C Komiyama; JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 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: 2012-09-28
• Decision Date: 2013-05-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07898237560823	K123022	000
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