LOCATOR R-Tx

Abutment, Implant, Dental, Endosseous

Ivory Super Holdco, Incp.

The following data is part of a premarket notification filed by Ivory Super Holdco, Incp. with the FDA for Locator R-tx.

Pre-market Notification Details

Device IDK200827
510k NumberK200827
Device Name:LOCATOR R-Tx
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Ivory Super Holdco, Incp. 2875 Locker Ave East Carlsbad,  CA  92010
ContactMarysa Loustalot
CorrespondentMarysa Loustalot
Ivory Super Holdco, Incp. 2875 Locker Ave East Carlsbad,  CA  92010
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-09-02

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