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 Mouthguard, Prescription
510(k) Number K232087
Device Name Dental LT Comfort Resin
Applicant
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Applicant Contact Ritika Sharma
Correspondent
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Correspondent Contact Nathan Alt
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received07/13/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-