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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
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
AIOBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASEPTICO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH,INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
DIPLOMAT DENTAL S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
ERGONOMIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOREST DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL DENTAL DIRECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALLIM DENTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEKA DENTAL A/S
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
LARES RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MGNEWTON LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDUSTRIA E COMERCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDÚSTRIA E COMÉRCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PELTON & CRANE
  SUBSTANTIALLY EQUIVALENT 2
PRO DENTAL SERVICES LLC.
  SUBSTANTIALLY EQUIVALENT 1
PROGENY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RITTER CONCEPT GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAFARI DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI DYNAMIC INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 2
SIRONA DENTAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 2
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THEROZONE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI SIGER MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 255 255
2015 452 452
2016 151 319
2017 64 222
2018 73 256
2019 68 196
2020 48 131
2021 48 121
2022 44 131
2023 53 135
2024 9 37

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 294 864
Device Displays Incorrect Message 188 234
Device Markings/Labelling Problem 148 216
Positioning Problem 99 99
Unintended Power Up 81 107
Device Remains Activated 75 112
Detachment of Device or Device Component 73 205
Device Operates Differently Than Expected 57 57
Disassembly 55 91
Component Missing 28 28
Fracture 24 61
Electrical /Electronic Property Problem 22 22
Fluid/Blood Leak 19 36
Break 18 20
Cut In Material 16 22
Unintended Movement 16 16
Leak/Splash 15 20
Mechanical Problem 14 14
Smoking 8 8
Material Disintegration 6 12
Unintended Ejection 4 5
Detachment Of Device Component 4 4
Component Falling 4 4
Metal Shedding Debris 4 4
Unintended System Motion 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Defective Device 3 3
Fail-Safe Problem 2 2
Unstable 2 2
Material Fragmentation 2 4
Device Alarm System 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Misconnection 1 1
Corroded 1 6
Thermal Decomposition of Device 1 1
Vibration 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Defective Component 1 1
Device Issue 1 1
No Device Output 1 1
Loose or Intermittent Connection 1 1
Device Maintenance Issue 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Failure to Shut Off 1 1
Inappropriate or Unexpected Reset 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Insufficient Information 1 1
Ejection Problem 1 1
Pressure Problem 1 1
Scratched Material 1 1
Device Unsafe to Use in Environment 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 879 1250
No Clinical Signs, Symptoms or Conditions 184 544
No Known Impact Or Consequence To Patient 111 227
No Consequences Or Impact To Patient 59 160
Burn(s) 51 203
Insufficient Information 12 61
No Information 9 17
Superficial (First Degree) Burn 7 77
Burn, Thermal 7 73
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Radiation Exposure, Unintended 1 1
Electric Shock 1 1
Foreign Body In Patient 1 1
Laceration(s) 1 1
Pain 1 1
Skin Discoloration 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1
Reaction 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASI Medical, Inc. II Dec-19-2013
2 Danville Materials, Inc. II Aug-12-2016
3 Pelton & Crane Company II Mar-06-2012
4 William C. Domb, D.M.D., A Professional Corporation II May-09-2014
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