GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM

Bracket, Ceramic, Orthodontic

ORTHO TECHNOLOGY, INC

The following data is part of a premarket notification filed by Ortho Technology, Inc with the FDA for Generation C Aesthetic Self-ligating Bracket System.

Pre-market Notification Details

• Device ID: K112707
• 510k Number: K112707
• Device Name: GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
• Classification: Bracket, Ceramic, Orthodontic
• Applicant: ORTHO TECHNOLOGY, INC 17401 COMMERCE PARK BLVD. Tampa, FL 33647
• Contact: Jodi Hutchins
• Correspondent: Jodi Hutchins; ORTHO TECHNOLOGY, INC 17401 COMMERCE PARK BLVD. Tampa, FL 33647
• Product Code: NJM
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-19
• Decision Date: 2012-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190707000448	K112707	000
00190707009489	K112707	000
00190707009496	K112707	000
00190707009502	K112707	000
00190707009519	K112707	000
00190707009526	K112707	000
00190707009533	K112707	000
00190707009540	K112707	000
00190707009557	K112707	000
00190707009564	K112707	000
00190707009571	K112707	000
00190707009588	K112707	000
00190707009472	K112707	000
00190707009465	K112707	000
00190707009458	K112707	000
00190707009342	K112707	000
00190707009359	K112707	000
00190707009366	K112707	000
00190707009373	K112707	000
00190707009380	K112707	000
00190707009397	K112707	000
00190707009403	K112707	000
00190707009410	K112707	000
00190707009427	K112707	000
00190707009434	K112707	000
00190707009441	K112707	000
00190707009595	K112707	000
00190730002907	K112707	000
00190730002914	K112707	000
00190730003065	K112707	000
00190730003072	K112707	000
00190730003089	K112707	000
00190730003096	K112707	000
00190730003102	K112707	000
00190730003119	K112707	000
00190730003126	K112707	000
00190730003133	K112707	000
00190730003140	K112707	000
00190730003157	K112707	000
00190730003164	K112707	000
00190730003058	K112707	000
00190730003041	K112707	000
00190730003034	K112707	000
00190730002921	K112707	000
00190730002938	K112707	000
00190730002945	K112707	000
00190730002952	K112707	000
00190730002969	K112707	000
00190730002976	K112707	000
00190730002983	K112707	000
00190730002990	K112707	000
00190730003003	K112707	000
00190730003010	K112707	000
00190730003027	K112707	000
00190730003171	K112707	000