Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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
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 2
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 25 74

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 497 1574
Detachment of Device or Device Component 406 1302
Detachment Of Device Component 75 75
Mechanical Problem 60 60
Use of Device Problem 22 22
Material Separation 20 20
Insufficient Information 17 17
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
Loose or Intermittent Connection 9 9
Device Maintenance Issue 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Misassembly by Users 9 9
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
Unintended Ejection 7 7
Entrapment of Device 4 4
Fitting Problem 4 8
Failure To Service 4 4
Retraction Problem 4 4
Migration or Expulsion 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
Activation, Positioning or Separation Problem 2 2
Physical Property Issue 2 2
Unintended Movement 2 2
Sticking 2 2
Device Reprocessing Problem 2 2
Inadequate Lubrication 2 2
Accessory Incompatible 1 1
Air Leak 1 1
Component Incompatible 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
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
Material Rupture 1 1
Inadequate Service 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 360 1892
Burn(s) 156 1070
Foreign Body In Patient 88 88
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
No Information 11 79
Laceration(s) 10 10
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
-
-