CLICK-IT

Bracket, Ceramic, Orthodontic

TP ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Tp Orthodontics, Inc. with the FDA for Click-it.

Pre-market Notification Details

• Device ID: K111234
• 510k Number: K111234
• Device Name: CLICK-IT
• Classification: Bracket, Ceramic, Orthodontic
• Applicant: TP ORTHODONTICS, INC. 100 CENTER PLAZA La Porte, IN 46350 -0073
• Contact: Robin Intagliata
• Correspondent: Paula Wilkerson; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: NJM
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2011-05-02
• Decision Date: 2011-05-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00192029007723	K111234	000
00192029007594	K111234	000
00192029007587	K111234	000
00192029007570	K111234	000
00192029007563	K111234	000
00192029007556	K111234	000
00192029007549	K111234	000
00192029007532	K111234	000
00192029007525	K111234	000
00192029007518	K111234	000
00192029007600	K111234	000
00192029007617	K111234	000
00192029007624	K111234	000
00192029007716	K111234	000
00192029007709	K111234	000
00192029007693	K111234	000
00192029007686	K111234	000
00192029007679	K111234	000
00192029007662	K111234	000
00192029007655	K111234	000
00192029007648	K111234	000
00192029007631	K111234	000
00192029007501	K111234	000