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 Crown And Bridge, Temporary, Resin
510(k) Number K240538
Device Name Premium Teeth Resin
Applicant
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Applicant Contact Paige Johnson
Correspondent
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Correspondent Contact Paige Johnson
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
PZY  
Date Received02/26/2024
Decision Date 07/19/2024
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
-
-