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 Bone Grafting Material, Synthetic
510(k) Number K213260
Device Name CMFlexTM
Applicant
Dimension Inx Corp.
3440 S Dearborn St. Suite 142s
Chicago,  IL  60616
Applicant Contact Ramille Shah
Correspondent
Dimension Inx Corp.
3440 S Dearborn St. Suite 142s
Chicago,  IL  60616
Correspondent Contact Ramille Shah
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/30/2021
Decision Date 12/30/2022
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
-
-