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 K214071
Device Name Hexa-Temp
Applicant
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722
Gojan-Dong, Namdong-Gu,  KR 405-821
Applicant Contact J.M. Ahn
Correspondent
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722
Gojan-Dong, Namdong-Gu,  KR 405-821
Correspondent Contact J.M. Ahn
Regulation Number872.3770
Classification Product Code
EBG  
Date Received12/27/2021
Decision Date 03/10/2022
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
-
-