• 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 system, x-ray, extraoral source, digital
Regulation Description Extraoral source x-ray system.
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
3DISC AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM DENTAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DENTTIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEXCOWIN CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DEXCOWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DUERR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
EDLEN IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIC INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
NICAL SPA
  SUBSTANTIALLY EQUIVALENT 1
OWANDY
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PANORAMIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
POINTNIX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SOPRO - ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 3
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VILLA SISTEMI MEDICALI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ZUMA DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device alarm system issue 2
Computer software issue 1
Instruction for use issue 1
Patient Data Issue 1
Electrical issue 1
No Known Device Problem 1
Total Device Problems 7

Recalls
Manufacturer Recall Class Date Posted
1 Carestream Health, Inc. II Apr-03-2015
2 Midmark Corp dba Progeny Inc II Jan-25-2016
3 Midmark Corp dba Progeny Inc II Jan-09-2014
4 Villa Radiology Systems LLC II Nov-06-2015

-
-