Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
handpiece, air-powered, dental
Product Code
EFB
Regulation Number
872.4200
Device Class
1
Premarket Reviews
Manufacturer
Decision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
DENTALEZ, INC.
SUBSTANTIALLY EQUIVALENT
2
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
1
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
SUBSTANTIALLY EQUIVALENT
1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
J. MORITA USA, INC.
SUBSTANTIALLY EQUIVALENT
1
KALTENBACH & VOIGT GMBH
SUBSTANTIALLY EQUIVALENT
1
MICROP TECHNOLOGY (TAIWAN), INC.
SUBSTANTIALLY EQUIVALENT
2
NAKANISHI, INC.
SUBSTANTIALLY EQUIVALENT
1
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PREMIUM PLUS INTERNATIONAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
TTBIO CORP.
SUBSTANTIALLY EQUIVALENT
1
W & H DENTALWERK BUERMOOS GMBH
SUBSTANTIALLY EQUIVALENT
1
W&H DENTALWERK BURMOOS GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
153
153
2018
81
81
2019
117
399
2020
94
334
2021
123
670
2022
71
314
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
281
948
Detachment of Device or Device Component
252
888
Detachment Of Device Component
39
39
Mechanical Problem
32
32
Use of Device Problem
11
11
Improper or Incorrect Procedure or Method
10
10
Device Slipped
10
10
Device Handling Problem
10
10
Device Maintenance Issue
8
8
Break
7
7
Dent in Material
7
7
Physical Resistance/Sticking
7
7
Maintenance Does Not Comply To Manufacturers Recommendations
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Component Falling
5
5
Unintended Ejection
5
5
Migration or Expulsion of Device
4
4
Device Operates Differently Than Expected
4
4
Device Dislodged or Dislocated
4
4
Material Separation
4
4
Fitting Problem
4
8
Device Fell
4
4
Misassembly by Users
4
4
Insufficient Information
3
3
Defective Device
3
8
Temperature Problem
3
3
Loose or Intermittent Connection
3
3
Entrapment of Device
3
3
Device Reprocessing Problem
2
2
Failure To Service
2
2
Activation, Positioning or SeparationProblem
2
2
Premature Separation
1
1
Failure to Clean Adequately
1
1
Misassembly During Maintenance/Repair
1
1
Noise, Audible
1
1
Inadequate Service
1
1
Problem with Sterilization
1
1
Vibration
1
1
Unintended Movement
1
1
Failure to Shut Off
1
1
Gas Leak
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Fail-Safe Design Failure
1
1
Use of Incorrect Control Settings
1
1
Disassembly
1
1
Material Fragmentation
1
1
Misassembled
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
284
732
No Clinical Signs, Symptoms or Conditions
182
1045
Burn(s)
77
603
Foreign Body In Patient
55
55
No Known Impact Or Consequence To Patient
28
28
Burn, Thermal
23
23
Patient Problem/Medical Problem
21
21
Injury
14
76
No Code Available
10
10
Insufficient Information
8
269
Tissue Damage
6
6
No Information
5
73
Superficial (First Degree) Burn
3
3
Swelling
3
3
Laceration(s)
3
3
Tooth Fracture
3
3
Choking
2
2
Pain
2
2
Partial thickness (Second Degree) Burn
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Cough
1
1
Scar Tissue
1
1
Pulmonary Emphysema
1
1
Hemorrhage/Bleeding
1
1
Abrasion
1
1
Air Embolism
1
1
Airway Obstruction
1
1
Chemical Exposure
1
1
-
-