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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
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
AEROBINE, INC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEYES DENTAL CANADA INC
  SUBSTANTIALLY EQUIVALENT 2
CODENT TECHNICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL SAVINGS CLUB
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ GROUP, STARDENTAL DIVISION
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ, INC.
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 5
EMS ELECTRO MEDICAL SYSTEMS SA
  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
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANDPIECE CLUB, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANDPIECE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 2
HANDPIECE HEADQUARTERS INC. - HPR INC.
  SUBSTANTIALLY EQUIVALENT 1
HARRY J. BOSWORTH CO.
  SUBSTANTIALLY EQUIVALENT 1
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
JAINTEK CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 2
KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
LARES RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LITU TECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRON CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICROP TECHNOLOGY (TAIWAN), INC.
  SUBSTANTIALLY EQUIVALENT 2
MODERN KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 3
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 5
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NSK AMERICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSPRAY LTD
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALM BEACH DENTAL SUPPLY D/B/A TEK USA
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRODRIVE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
REDENT-NOVA LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENT. INC.
  SUBSTANTIALLY EQUIVALENT 1
SABLE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREJOY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIRONA DENTAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THUNDER TIGER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 3
W & H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 3
W&H DENTALWERK BURMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 73 73
2015 87 87
2016 122 122
2017 153 153
2018 81 81
2019 117 399
2020 94 334
2021 123 670
2022 157 637
2023 117 501
2024 41 171

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 506 1664
Detachment of Device or Device Component 410 1306
Detachment Of Device Component 75 75
Mechanical Problem 61 61
Use of Device Problem 22 22
Material Separation 20 20
Insufficient Information 18 18
Temperature Problem 16 16
Break 15 15
Improper or Incorrect Procedure or Method 14 14
Dent in Material 14 14
Device Handling Problem 13 13
Component Falling 12 12
Device Slipped 10 10
Misassembly by Users 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Loose or Intermittent Connection 9 9
Device Maintenance Issue 9 9
Unintended Ejection 7 7
Physical Resistance/Sticking 7 7
Excessive Heating 7 7
Device Operates Differently Than Expected 7 7
Device Dislodged or Dislocated 7 7
Maintenance Does Not Comply To Manufacturers Recommendations 7 7
Retraction Problem 5 5
Failure To Service 4 4
Migration or Expulsion of Device 4 4
Fitting Problem 4 8
Entrapment of Device 4 4
Device Fell 4 4
Unintended Electrical Shock 4 4
Defective Device 3 8
Device Contamination with Chemical or Other Material 2 2
Physical Property Issue 2 2
Unintended Movement 2 2
Activation, Positioning or Separation Problem 2 2
Component Incompatible 2 2
Device Reprocessing Problem 2 2
Accessory Incompatible 2 2
Sticking 2 2
Inadequate Lubrication 2 2
Device Stops Intermittently 1 1
Smoking 1 1
Problem with Sterilization 1 1
Component Missing 1 1
Device Issue 1 1
Misassembled 1 1
Misconnection 1 1
Difficult to Remove 1 1
Inadequate Service 1 1
Material Rupture 1 1
Air Leak 1 1
Use of Incorrect Control/Treatment Settings 1 1
Decoupling 1 1
Disassembly 1 1
Fail-Safe Design Failure 1 1
Material Fragmentation 1 1
Leak/Splash 1 1
Melted 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Premature Separation 1 1
Failure to Clean Adequately 1 1
Misassembly During Maintenance/Repair 1 1
Gas/Air Leak 1 1
Installation-Related Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Vibration 1 1
Patient-Device Incompatibility 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 438 886
No Clinical Signs, Symptoms or Conditions 369 1982
Burn(s) 161 1155
Foreign Body In Patient 92 92
No Known Impact Or Consequence To Patient 55 55
Burn, Thermal 46 46
Patient Problem/Medical Problem 26 26
Insufficient Information 24 402
Injury 20 82
No Code Available 18 18
Laceration(s) 12 12
No Information 11 79
Swelling 6 6
Tissue Damage 6 6
Pain 5 5
Superficial (First Degree) Burn 5 5
Tooth Fracture 3 3
Choking 3 3
Pulmonary Emphysema 3 3
Hemorrhage/Bleeding 2 2
Complaint, Ill-Defined 2 2
Chemical Exposure 2 2
Partial thickness (Second Degree) Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cough 1 1
Skin Tears 1 1
Burning Sensation 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Hepatitis 1 1
Abrasion 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coltene Whaledent Inc II Mar-02-2023
2 MTI Precision Products LLC. II Jul-12-2014
3 Nakanishi Inc. II Aug-26-2016
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