CLARITY MODIFIED CERAMIC BRACKETS

Bracket, Ceramic, Orthodontic

3M UNITEK

The following data is part of a premarket notification filed by 3m Unitek with the FDA for Clarity Modified Ceramic Brackets.

Pre-market Notification Details

• Device ID: K062305
• 510k Number: K062305
• Device Name: CLARITY MODIFIED CERAMIC BRACKETS
• Classification: Bracket, Ceramic, Orthodontic
• Applicant: 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016
• Contact: L Marlyn Scheff
• Correspondent: L Marlyn Scheff; 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016
• Product Code: NJM
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-08
• Decision Date: 2006-10-18

NIH GUDID Devices

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