PREFORMED TOOTH POSITIONER

Positioner, Tooth, Preformed

TP LABORATORIES, INC.

The following data is part of a premarket notification filed by Tp Laboratories, Inc. with the FDA for Preformed Tooth Positioner.

Pre-market Notification Details

• Device ID: K780619
• 510k Number: K780619
• Device Name: PREFORMED TOOTH POSITIONER
• Classification: Positioner, Tooth, Preformed
• Applicant: TP LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KMY
• CFR Regulation Number: 872.5525 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-04-13
• Decision Date: 1978-06-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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