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 Dental Stereotaxic Instrument
510(k) Number K202100
Device Name Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
Applicant
Neocis Inc.
2800 Biscayne Blvd Suite 600
Miami,  FL  33137
Applicant Contact Thomas E Claiborne
Correspondent
Neocis Inc.
2800 Biscayne Blvd Suite 600
Miami,  FL  33137
Correspondent Contact Thomas E Claiborne
Regulation Number872.4120
Classification Product Code
PLV  
Date Received07/29/2020
Decision Date 10/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-