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
Regulation Description Dental handpiece and accessories.
Product CodeEFB
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SOCO PRECISION INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG JINME MEDICAL TECHNOLOGY 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
LITU TECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROP TECHNOLOGY (TAIWAN), INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 4
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 1
W&H DENTALWERK BÜRMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 94 334
2021 123 670
2022 157 637
2023 117 501
2024 104 375
2025 15 64

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 341 1059
Overheating of Device 149 1393
Mechanical Problem 39 39
Insufficient Information 17 17
Use of Device Problem 14 14
Retraction Problem 9 9
Excessive Heating 9 9
Temperature Problem 8 8
Dent in Material 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Physical Resistance/Sticking 5 5
Material Integrity Problem 5 5
Break 4 4
Unintended Electrical Shock 4 4
Misassembly by Users 4 4
Fitting Problem 3 7
Entrapment of Device 3 3
Accessory Incompatible 3 3
Defective Device 3 8
Unintended Ejection 3 3
Device Handling Problem 3 3
Device Dislodged or Dislocated 3 3
Component Incompatible 3 3
Improper or Incorrect Procedure or Method 3 3
Device Slipped 2 2
Activation, Positioning or Separation Problem 2 2
Burst Container or Vessel 2 2
Inadequate Lubrication 2 2
Device Damaged by Another Device 2 2
Material Separation 2 2
No Apparent Adverse Event 2 2
Loose or Intermittent Connection 2 2
Device Fell 1 1
Vibration 1 1
Component Missing 1 1
Premature Separation 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 413 2216
Burn(s) 96 1152
Foreign Body In Patient 54 54
No Consequences Or Impact To Patient 51 218
Insufficient Information 28 406
Laceration(s) 12 12
Superficial (First Degree) Burn 11 11
Burn, Thermal 5 5
Injury 4 66
Patient Problem/Medical Problem 3 3
Pain 3 3
Choking 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 1 1
No Information 1 20
Asthma 1 1
No Known Impact Or Consequence To Patient 1 1
Scar Tissue 1 1
Cough 1 1
Skin Tears 1 1
Partial thickness (Second Degree) Burn 1 1
Hemorrhage/Bleeding 1 1

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