SAPPHIRE CERAMIC BRACKET

Bracket, Ceramic, Orthodontic

ORTHO TECHNOLOGY, INC

The following data is part of a premarket notification filed by Ortho Technology, Inc with the FDA for Sapphire Ceramic Bracket.

Pre-market Notification Details

• Device ID: K073045
• 510k Number: K073045
• Device Name: SAPPHIRE CERAMIC BRACKET
• Classification: Bracket, Ceramic, Orthodontic
• Applicant: ORTHO TECHNOLOGY, INC 17401 COMMERCE PARK BLVD. Tampa, FL 33647
• Contact: Paul Williams
• Correspondent: Paul Williams; 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: 2007-10-29
• Decision Date: 2007-12-18

NIH GUDID Devices

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