ELEVANCE

Unit, Operative Dental

MIDMARK

The following data is part of a premarket notification filed by Midmark with the FDA for Elevance.

Pre-market Notification Details

• Device ID: K120239
• 510k Number: K120239
• Device Name: ELEVANCE
• Classification: Unit, Operative Dental
• Applicant: MIDMARK 1801 EDGECLIFF DRIVE Fullerton, CA 92831
• Contact: Robyn Scopis
• Correspondent: Robyn Scopis; MIDMARK 1801 EDGECLIFF DRIVE Fullerton, CA 92831
• Product Code: EIA
• CFR Regulation Number: 872.6640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-26
• Decision Date: 2012-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841709109744	K120239	000
00841709109737	K120239	000
00841709109720	K120239	000
00841709109713	K120239	000