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FDA 510(k) Applications Submitted by Quanzu Yang
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130312
02/07/2013
IROOT FM
INNOVATIVE BIOCERAMIX INC.
K080917
04/01/2008
IROOT SP
INNOVATIVE BIOCERAMIX INC.
K231259
05/01/2023
iRoot SP Plus
Innovative BioCeramix, Inc.
K092715
09/03/2009
IROOT BP PLUS
INNOVATIVE BIOCERAMIX INC.
K222992
09/28/2022
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
Innovative BioCeramix Inc.
K102867
09/30/2010
IROOT FS
INNOVATIVE BIOCERAMIX INC.
K082943
10/02/2008
IROOT BP, MODEL IRBP 4609
INNOVATIVE BIOCERAMIX INC.
K063422
11/13/2006
BIOAGGREGATE
INNOVATIVE BIOCERAMIX INC.
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