Ready-Fit

Mouthguard, Over-the-counter

DENTEK ORAL CARE, INC.

The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for Ready-fit.

Pre-market Notification Details

• Device ID: K151149
• 510k Number: K151149
• Device Name: Ready-Fit
• Classification: Mouthguard, Over-the-counter
• Applicant: DENTEK ORAL CARE, INC. 397 EXCELLENCE WAY Maryville, TN 37801
• Contact: Linda Giles
• Correspondent: Linda Giles; DENTEK ORAL CARE, INC. 397 EXCELLENCE WAY Maryville, TN 37801
• Product Code: OBR
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-30
• Decision Date: 2015-09-30