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TPLC
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show TPLC since
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2024
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Device
drill, bone, powered
Product Code
DZI
Regulation Number
872.4120
Device Class
2
Premarket Reviews
Manufacturer
Decision
BENNETT JACOBY, DDS, MS, INC.
SUBSTANTIALLY EQUIVALENT
1
BONART CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
DMETEC CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
DONG IL TECHNOLOGY LTD.
SUBSTANTIALLY EQUIVALENT
2
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
SUBSTANTIALLY EQUIVALENT
2
MECTRON S.P.A
SUBSTANTIALLY EQUIVALENT
1
MECTRON S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MECTRON SPA
SUBSTANTIALLY EQUIVALENT
2
PIEZOSURGERY S.R.L.
SUBSTANTIALLY EQUIVALENT
1
SAESHIN PRECISION CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SATELEC
SUBSTANTIALLY EQUIVALENT
2
SATELEC - ACTEON GROUP
SUBSTANTIALLY EQUIVALENT
1
SATELEC - ACTEON, INC.
SUBSTANTIALLY EQUIVALENT
1
SILFRADENT S.R.L.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA)
SUBSTANTIALLY EQUIVALENT
1
W & H DENTALWERK BUERMOOS GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
50
50
2015
39
39
2016
43
43
2017
38
38
2018
73
73
2019
50
50
2020
55
55
2021
84
84
2022
63
64
2023
63
63
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
336
336
Failure to Cut
63
63
Device-Device Incompatibility
57
57
Entrapment of Device
45
45
Overheating of Device
20
20
Material Twisted/Bent
17
17
Material Fragmentation
15
15
Device Operates Differently Than Expected
14
14
Device Markings/Labelling Problem
12
12
Fracture
8
8
Detachment Of Device Component
5
5
Device Stops Intermittently
5
5
Detachment of Device or Device Component
5
6
Material Deformation
5
5
Naturally Worn
4
4
Separation Failure
4
4
Dull, Blunt
4
4
Defective Device
4
4
Use of Device Problem
4
4
Difficult to Insert
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Temperature Problem
3
3
No Apparent Adverse Event
3
3
Packaging Problem
2
2
Mechanical Problem
2
2
Device Inoperable
2
2
Failure To Adhere Or Bond
2
2
Failure to Osseointegrate
2
2
Component or Accessory Incompatibility
2
2
Connection Problem
1
1
Failure to Align
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Component Missing
1
1
Device Or Device Fragments Location Unknown
1
1
Ambient Noise Problem
1
1
Contamination /Decontamination Problem
1
1
Bent
1
1
Thermal Decomposition of Device
1
1
Component Falling
1
1
Component Incompatible
1
1
Peeled/Delaminated
1
1
Difficult To Position
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Sticking
1
1
Positioning Problem
1
1
Unintended Movement
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Excessive Heating
1
1
Missing Information
1
1
Osseointegration Problem
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
Material Distortion
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
169
170
No Known Impact Or Consequence To Patient
134
134
No Consequences Or Impact To Patient
86
86
Foreign Body In Patient
56
56
No Patient Involvement
33
33
No Code Available
31
31
Insufficient Information
26
26
Failure of Implant
20
20
Device Embedded In Tissue or Plaque
19
19
No Information
9
9
Burn(s)
8
8
Sedation
8
8
Injury
3
3
Necrosis
3
3
Not Applicable
3
3
Unspecified Tissue Injury
3
3
Impaired Healing
2
2
Pain
2
2
Osteopenia/ Osteoporosis
1
1
Numbness
1
1
Burn, Thermal
1
1
Nerve Damage
1
1
Vessel Or Plaque, Device Embedded In
1
1
Unspecified Infection
1
1
Laceration(s)
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Nobel Biocare Usa Llc
II
Feb-19-2020
2
Nobel Biocare Usa Llc
II
Aug-09-2016
3
Stryker Instruments Div. of Stryker Corporation
II
Nov-16-2009
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