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Lab talk, the good, the bad, and the ugly
Dental-CAM
FDA AND NT-TRADING
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<blockquote data-quote="erykd1" data-source="post: 349774" data-attributes="member: 9989"><p>This is from an email I received from Alien Milling, seems like an issue between NT Trading and the FDA:</p><h3>FDA Ship-Hold Notice for NT Trading </h3><p>We have been notified by NT-Trading GmbH Co, KG that their premarket clearance K111935 may not cover certain products, specifically Preform Milling Blanks, Titanium NX Bases, Certain series of Titanium Bases, and certain series of 2-CONnect and LocOn Products. </p><p></p><h3>NT Products affected</h3> <ul> <li data-xf-list-type="ul">TiBases<br /> Series BEG, BIO, BRE, CAM, COL, HIO, MEG, MEX, MIC, MIS, NEO, SEV, THO, UPR, Y </li> <li data-xf-list-type="ul">Preform Milling Blanks: all Series</li> <li data-xf-list-type="ul">2CONnect and LOcON:<br /> Series BEG, BIO, BRE, CAM, COL, F, HIO, H, I, K, MEG, MEX, MIC, MIS, NEO, R, SEV, S, THO, T, UPR, UTG, Y</li> </ul><p>NT Trading is in correspondence with the FDA to clarify and resolve the situation as soon as possible. However, they do not expect a response sooner than 6/15/2022. </p><p>We will be monitoring the situation and will update you when we hear more from NT Trading.</p></blockquote><p></p>
[QUOTE="erykd1, post: 349774, member: 9989"] This is from an email I received from Alien Milling, seems like an issue between NT Trading and the FDA: [HEADING=2]FDA Ship-Hold Notice for NT Trading [/HEADING] We have been notified by NT-Trading GmbH Co, KG that their premarket clearance K111935 may not cover certain products, specifically Preform Milling Blanks, Titanium NX Bases, Certain series of Titanium Bases, and certain series of 2-CONnect and LocOn Products. [HEADING=2]NT Products affected[/HEADING] [LIST] [*]TiBases Series BEG, BIO, BRE, CAM, COL, HIO, MEG, MEX, MIC, MIS, NEO, SEV, THO, UPR, Y [*]Preform Milling Blanks: all Series [*]2CONnect and LOcON: Series BEG, BIO, BRE, CAM, COL, F, HIO, H, I, K, MEG, MEX, MIC, MIS, NEO, R, SEV, S, THO, T, UPR, UTG, Y [/LIST] NT Trading is in correspondence with the FDA to clarify and resolve the situation as soon as possible. However, they do not expect a response sooner than 6/15/2022. We will be monitoring the situation and will update you when we hear more from NT Trading. [/QUOTE]
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Lab talk, the good, the bad, and the ugly
Dental-CAM
FDA AND NT-TRADING
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