Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Resin, Root Canal Filling
510(k) Number K222992
Device Name iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
Applicant
Innovative Bioceramix, Inc.
101-8218 N. Fraser Way
Burnaby,  CA V3N0E9
Applicant Contact Quanzu Yang
Correspondent
Innovative Bioceramix, Inc.
101-8218 N. Fraser Way
Burnaby,  CA V3N039
Correspondent Contact Quanzu Yang
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/28/2022
Decision Date 11/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-