DETECT

Locator, Root Apex

FORUM ENGINEERING TECHNOLOGIES LTD

The following data is part of a premarket notification filed by Forum Engineering Technologies Ltd with the FDA for Detect.

Pre-market Notification Details

• Device ID: K121206
• 510k Number: K121206
• Device Name: DETECT
• Classification: Locator, Root Apex
• Applicant: FORUM ENGINEERING TECHNOLOGIES LTD 1 PLATIN ST, NEW INDUSTRIAL ZONE Rishon Lezion, IL 75653
• Contact: Yuliya Yukevich
• Correspondent: Yuliya Yukevich; FORUM ENGINEERING TECHNOLOGIES LTD 1 PLATIN ST, NEW INDUSTRIAL ZONE Rishon Lezion, IL 75653
• Product Code: LQY
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-20
• Decision Date: 2013-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887919972228	K121206	000
00887919972198	K121206	000
00887919972167	K121206	000
00887919972136	K121206	000
00887919972105	K121206	000
00887919972075	K121206	000
07290114354004	K121206	000
07290114353205	K121206	000
07290114350006	K121206	000