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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, operative dental
Regulation Description Dental operative unit and accessories.
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
DANAHER
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
FOREST DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEKA DENTAL A/S
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RITTER CONCEPT GMBH
  SUBSTANTIALLY EQUIVALENT 1
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THEROZONE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 452 452
2016 151 151
2017 64 64
2018 73 73
2019 68 68
2020 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 148 148
Overheating of Device 143 143
Device Displays Incorrect Message 130 130
Positioning Problem 99 99
Unintended Power Up 62 62
Device Remains Activated 50 50
Device Operates Differently Than Expected 40 40
Disassembly 36 36
Detachment of Device or Device Component 34 34
Electrical /Electronic Property Problem 17 17
Break 14 14
Unintended Movement 13 13
Leak/Splash 11 11
Fluid Leak 11 11
Component Missing 11 11
Cut In Material 10 10
Mechanical Problem 8 8
Fracture 6 6
Smoking 5 5
Metal Shedding Debris 3 3
Unstable 2 2
Unintended System Motion 2 2
Handpiece 2 2
Switch, Push Button 1 1
Pressure Problem 1 1
Scratched Material 1 1
Peeled/Delaminated 1 1
Defective Component 1 1
Device Unsafe to Use in Environment 1 1
Electrical Power Problem 1 1
Fail-Safe Problem 1 1
Inappropriate or Unexpected Reset 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Loose or Intermittent Connection 1 1
Device Maintenance Issue 1 1
Misassembled 1 1
Misconnection 1 1
Wire 1 1
Switches 1 1
Foot Pedal 1 1
Device Alarm System 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Retraction Problem 1 1
Defective Device 1 1
Device Issue 1 1
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
No Device Output 1 1
Cord 1 1
Material Disintegration 1 1
Unintended Ejection 1 1
Failure to Shut Off 1 1
Tip 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 693 694
No Known Impact Or Consequence To Patient 58 58
No Consequences Or Impact To Patient 53 53
Burn(s) 30 30
Burn, Thermal 7 7
No Information 6 6
Superficial (First Degree) Burn 6 6
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 2 2
Radiation Exposure, Unintended 1 1
No Code Available 1 1
Electric Shock 1 1
Foreign Body In Patient 1 1
Anaphylactic Shock 1 1
Laceration(s) 1 1
Pain 1 1
Reaction 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Danville Materials, Inc. II Aug-12-2016
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