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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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9 records meeting your search criteria returned- Product Code: NXC Product Problem: Product Quality Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
SMILEDIRECTCLUB S.A. SMILE DIRECT ALIGNERS 04/12/2023
STRAIGHT SMILE, LLC BYTE INVISIBLE ALIGNERS 08/09/2022
SMILEDIRECTCLUB S.A. ORTHODONTIC ALIGNERS 08/03/2021
SMILE DIRECT CLUB / ALIGN TECHNOLOGY, IN SMILE DIRECT CLUB ALIGNERS 03/09/2021
ALIGN TECHNOLOGY, INC. INVISALIGN 11/06/2020
SMILEDIRECTCLUB /ALIGN TECHNOLOGY, INC. NIGHTTIME ALIGNER KIT 04/07/2020
SMILEDIRECTCLUB /ALIGN TECHNOLOGY, INC. NIGHTTIME ALIGNER KIT 04/07/2020
SMILE DIRECT CLUB / ALIGN TECHNOLOGY INC SMILE DIRECT CLUB INVISIBLE ALIGNERS 02/14/2020
ALIGN TECHNOLOGY INC. INVISALIGN CLEAR ALIGNERS AND INVISALIGN 01/30/2020
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