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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device dental barriers and sleeves
Definition Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Product CodePEM
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
AIR TECHNIQUES INC.
  SUBSTANTIALLY EQUIVALENT 1
BH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
MINITUBE AB
  SUBSTANTIALLY EQUIVALENT 1
PLASDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS (DONGGUAN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
UNIPACK MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
YONGQING HUAGUAN DENTAL INSTRUMENTS FACTORY
  SUBSTANTIALLY EQUIVALENT 1

-
-