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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, air-powered, dental
Product CodeEFB
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DENTALEZ, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
JAINTEK CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
MICROP TECHNOLOGY (TAIWAN), INC.
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREJOY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 81 81
2019 117 399
2020 94 334
2021 123 670
2022 157 637
2023 115 501

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 361 1259
Overheating of Device 212 1240
Mechanical Problem 44 44
Use of Device Problem 13 13
Insufficient Information 12 12
Device Handling Problem 10 10
Improper or Incorrect Procedure or Method 8 8
Device Slipped 8 8
Detachment Of Device Component 8 8
Break 7 7
Physical Resistance/Sticking 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Misassembly by Users 7 7
Excessive Heating 6 6
Dent in Material 6 6
Temperature Problem 5 5
Device Maintenance Issue 4 4
Device Fell 4 4
Unintended Electrical Shock 4 4
Device Dislodged or Dislocated 4 4
Material Separation 4 4
Fitting Problem 4 8
Component Falling 4 4
Entrapment of Device 3 3
Unintended Ejection 3 3
Loose or Intermittent Connection 3 3
Defective Device 3 8
Activation, Positioning or Separation Problem 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Retraction Problem 2 2
Device Reprocessing Problem 2 2
Inadequate Lubrication 2 2
Premature Separation 1 1
Failure to Clean Adequately 1 1
Misassembly During Maintenance/Repair 1 1
Noise, Audible 1 1
Unintended Movement 1 1
Fail-Safe Design Failure 1 1
Component Incompatible 1 1
Use of Incorrect Control/Treatment Settings 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Accessory Incompatible 1 1
Material Fragmentation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Failure to Shut Off 1 1
Gas/Air Leak 1 1
Component Missing 1 1
Vibration 1 1
Failure To Service 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 1829
No Consequences Or Impact To Patient 176 624
Burn(s) 93 963
Foreign Body In Patient 55 55
Insufficient Information 20 398
Burn, Thermal 19 19
No Known Impact Or Consequence To Patient 18 18
Patient Problem/Medical Problem 14 14
Injury 11 73
No Code Available 7 7
Superficial (First Degree) Burn 5 5
Laceration(s) 5 5
Tissue Damage 5 5
Swelling 3 3
Choking 3 3
No Information 3 71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pain 2 2
Scar Tissue 1 1
Pulmonary Emphysema 1 1
Hemorrhage/Bleeding 1 1
Abrasion 1 1
Air Embolism 1 1
Skin Tears 1 1
Chemical Exposure 1 1
Cough 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coltene Whaledent Inc II Mar-02-2023
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