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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
EAQ
Detector, Ultraviolet
2
Product Code
DYN
Mouthpiece, Saliva Ejector
1
Product Code
EBR
Unit, Suction Operatory
1
Product Code
EBZ
Activator, Ultraviolet, For Polymerization
2
Product Code
ECC
Sterilizer, Glass Bead
3
Product Code
ECG
Sterilizer, Boiling Water
1
Product Code
EEA
Plate, Base, Shellac
1
Product Code
EEF
Clamp, Rubber Dam
1
Product Code
EEG
Heat Source For Bleaching Teeth
1
Product Code
EEJ
Guard, Disk
1
Product Code
EFC
Warmer, Anesthetic Tube
1
Product Code
EFH
Paper, Articulation
1
Product Code
EFN
Cotton, Roll
1
Product Code
EFS
Unit, Oral Irrigation
1
Product Code
EFW
Toothbrush, Manual
1
Product Code
EFX
Protector, Silicate
1
Product Code
EGD
Wax, Dental, Intraoral
1
Product Code
EHJ
Disk, Abrasive
1
Product Code
EHK
Cup, Prophylaxis
1
Product Code
EHL
Point, Abrasive
1
Product Code
EHM
Strip, Polishing Agent
1
Product Code
EHY
Tray, Impression, Preformed
1
Product Code
EHZ
Evacuator, Oral Cavity
1
Product Code
EIA
Unit, Operative Dental
1
Product Code
EIE
Dam, Rubber
1
Product Code
EIH
Powder, Porcelain
2
Product Code
EJE
Frame, Rubber Dam
1
Product Code
EJG
Forceps, Rubber Dam Clamp
1
Product Code
EJI
Syringe, Cartridge
2
Product Code
EJQ
Wheel, Polishing Agent
1
Product Code
EJR
Agent, Polishing, Abrasive, Oral Cavity
1
Product Code
JEQ
Toothbrush, Powered
1
Product Code
K
20
0881
Oral-B iO Test Drive Power Brush Trial Program Kit
1
Cleared 510(K)
K
14
1018
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
1
Cleared 510(K)
K
06
1351
ORAL-B SONIC COMPLETE
1
Cleared 510(K)
K
06
1199
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
1
Cleared 510(K)
K
04
0416
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
1
Cleared 510(K)
K
02
2900
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
1
Cleared 510(K)
K
01
2914
SONICWAVE SONIC PLAQUE REMOVER
1
Cleared 510(K)
K
97
0381
POWERED TOOTHBRUSH
1
Cleared 510(K)
K
94
3942
TRAV-LER KIT
1
Cleared 510(K)
K
94
5248
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
1
Cleared 510(K)
K
94
4084
JENERIC/PENTRON P0WERED TOOTHBRUST
1
Cleared 510(K)
K
94
2634
PEMBUSH
1
Cleared 510(K)
K
94
1209
MY BEAT POWERED TOOTHBRUSH
1
Cleared 510(K)
K
94
1243
ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH
1
Cleared 510(K)
K
94
0288
WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
1
Cleared 510(K)
K
93
5150
SONIPLAK
1
Cleared 510(K)
K
93
5149
SONIBRUSH
1
Cleared 510(K)
K
93
5148
SONIFLOSS
1
Cleared 510(K)
K
93
6076
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
1
Cleared 510(K)
K
93
5561
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
1
Cleared 510(K)
K
93
3829
PULSE ELECTRIC TOOTHBRUSH
1
Cleared 510(K)
K
93
1360
ELECTRIC TOOTH-BRUSH
1
Cleared 510(K)
K
92
6246
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
1
Cleared 510(K)
K
92
6247
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
1
Cleared 510(K)
K
91
3724
SONEX ULTRASONIC TOOTH BRUSH
1
Cleared 510(K)
K
92
4739
THE DENTIST'S TOOTH POLISHER
1
Cleared 510(K)
K
92
1773
TX ELECTRIC TOOTHBRUSH
1
Cleared 510(K)
K
92
0644
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND
1
Cleared 510(K)
K
91
4198
POWER FLOSS AND BRUSH EW 129 & EW 120
1
Cleared 510(K)
K
91
0610
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
1
Cleared 510(K)
K
90
3488
MERIDIEN DENTAL SYSTEMS
1
Cleared 510(K)
K
90
4401
BATTERY-POWERED TOOTHBRUSH
1
Cleared 510(K)
K
90
3510
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
1
Cleared 510(K)
K
90
1963
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
1
Cleared 510(K)
K
90
0766
EPI DENT TOOTHBRUSH
1
Cleared 510(K)
K
89
6245
PLAK TRAC POWERED TOOTHBRUSH
1
Cleared 510(K)
K
89
3736
HOT BRUSH
1
Cleared 510(K)
K
89
1694
THE SMILE MACHINE
1
Cleared 510(K)
K
88
0589
ROTA-DENT TOOTH CLEANER
1
Cleared 510(K)
K
87
1929
PROBRIGHT TOOTH POLISHER
1
Cleared 510(K)
K
87
1406
THE WOOG ORABRUSH
1
Cleared 510(K)
K
86
2224
THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES
1
Cleared 510(K)
K
86
0264
SCHERER PORTABLE TOOTH POLISHER
1
Cleared 510(K)
K
85
4326
NO FLOSS FLOSSER
1
Cleared 510(K)
K
85
2476
INTERPLAK
1
Cleared 510(K)
K
85
2279
SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201
1
Cleared 510(K)
K
85
0562
FLOSSAGE - ELECTRIC TOOTHFLOSSER
1
Cleared 510(K)
K
82
0537
ULTRASONIC TOOTHBRUSH
1
Cleared 510(K)
K
82
0503
SVENSK TK/2
1
Cleared 510(K)
K
81
0805
WATER PIK AUTOMATIC TOOTHBRUSH
1
Cleared 510(K)
K
81
0666
BRAUN TRAVEL
1
Cleared 510(K)
K
78
0360
MASSAGER, GUM/SSAGE POWERED GUM
1
Cleared 510(K)
K
77
0997
PRO-CARE
1
Cleared 510(K)
K
77
0116
PORTA-PRO TOOTH POLISHER
1
Cleared 510(K)
JES
Floss, Dental
1
Product Code
JET
Pick, Massaging
1
Product Code
JEW
Tip, Rubber, Oral Hygiene
1
Product Code
KCQ
Tube Impression And Matrix
1
Product Code
KHR
Absorber, Saliva, Paper
1
Product Code
KLC
Chair, Dental, With Operative Unit
1
Product Code
KMT
Tray, Fluoride, Disposable
1
Product Code
KOJ
Airbrush
2
Product Code
KOK
Sterilizer, Endodontic Dry Heat
3
Product Code
LCN
Scraper, Tongue
1
Product Code
MAU
Eraser, Dental Stain
1
Product Code
MCF
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
1
Product Code
MMD
Toothbrush, Ionic, Battery-Powered
1
Product Code
NOB
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
1
Product Code
NRD
Unit, Operative Dental, Accessories
1
Product Code
NRU
Chair, Dental, Without Operative Unit
1
Product Code
NXV
Diagnostic Light, Soft Tissue Detector
2
Product Code
NXZ
Dental Hygiene Kit
1
Product Code
PIP
Prophy Powder, Airbrush Accessory
2
Product Code
OFX
General Purpose Dental Tray
1
Product Code
PFL
Intraoral, Dental Foam Protector
1
Product Code
QGO
Composite Resin Warmer
1
Product Code
QIA
Powered Tongue Scraper
1
Product Code
QJC
Plaque Disclosing Agent
1
Product Code
QMJ
Powered Radiofrequency Toothbrush
2
Product Code
QNF
Laser Activator For Polymerization
2
Product Code
QYJ
Dental Waterline Treatment Cartridge
1
Product Code
Ear, Nose, Throat
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Review Panel
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Review Panel
Hematology
Review Panel
Immunology
Review Panel
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Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 23 May 2025 at 11:06 pm
DE
/
subpart-g—miscellaneous-devices
/
JEQ
/
K871406
View Source
THE WOOG ORABRUSH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871406
510(k) Type
Traditional
Applicant
WOOG INTL.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/7/1987
Days to Decision
90 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
EAQ
Detector, Ultraviolet
DYN
Mouthpiece, Saliva Ejector
EBR
Unit, Suction Operatory
EBZ
Activator, Ultraviolet, For Polymerization
ECC
Sterilizer, Glass Bead
ECG
Sterilizer, Boiling Water
EEA
Plate, Base, Shellac
EEF
Clamp, Rubber Dam
EEG
Heat Source For Bleaching Teeth
EEJ
Guard, Disk
EFC
Warmer, Anesthetic Tube
EFH
Paper, Articulation
EFN
Cotton, Roll
EFS
Unit, Oral Irrigation
EFW
Toothbrush, Manual
EFX
Protector, Silicate
EGD
Wax, Dental, Intraoral
EHJ
Disk, Abrasive
EHK
Cup, Prophylaxis
EHL
Point, Abrasive
EHM
Strip, Polishing Agent
EHY
Tray, Impression, Preformed
EHZ
Evacuator, Oral Cavity
EIA
Unit, Operative Dental
EIE
Dam, Rubber
EIH
Powder, Porcelain
EJE
Frame, Rubber Dam
EJG
Forceps, Rubber Dam Clamp
EJI
Syringe, Cartridge
EJQ
Wheel, Polishing Agent
EJR
Agent, Polishing, Abrasive, Oral Cavity
JEQ
Toothbrush, Powered
K
20
0881
Oral-B iO Test Drive Power Brush Trial Program Kit
K
14
1018
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
K
06
1351
ORAL-B SONIC COMPLETE
K
06
1199
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
K
04
0416
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K
02
2900
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K
01
2914
SONICWAVE SONIC PLAQUE REMOVER
K
97
0381
POWERED TOOTHBRUSH
K
94
3942
TRAV-LER KIT
K
94
5248
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
K
94
4084
JENERIC/PENTRON P0WERED TOOTHBRUST
K
94
2634
PEMBUSH
K
94
1209
MY BEAT POWERED TOOTHBRUSH
K
94
1243
ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH
K
94
0288
WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
K
93
5150
SONIPLAK
K
93
5149
SONIBRUSH
K
93
5148
SONIFLOSS
K
93
6076
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K
93
5561
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K
93
3829
PULSE ELECTRIC TOOTHBRUSH
K
93
1360
ELECTRIC TOOTH-BRUSH
K
92
6246
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K
92
6247
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K
91
3724
SONEX ULTRASONIC TOOTH BRUSH
K
92
4739
THE DENTIST'S TOOTH POLISHER
K
92
1773
TX ELECTRIC TOOTHBRUSH
K
92
0644
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND
K
91
4198
POWER FLOSS AND BRUSH EW 129 & EW 120
K
91
0610
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K
90
3488
MERIDIEN DENTAL SYSTEMS
K
90
4401
BATTERY-POWERED TOOTHBRUSH
K
90
3510
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
K
90
1963
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
K
90
0766
EPI DENT TOOTHBRUSH
K
89
6245
PLAK TRAC POWERED TOOTHBRUSH
K
89
3736
HOT BRUSH
K
89
1694
THE SMILE MACHINE
K
88
0589
ROTA-DENT TOOTH CLEANER
K
87
1929
PROBRIGHT TOOTH POLISHER
K
87
1406
THE WOOG ORABRUSH
K
86
2224
THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES
K
86
0264
SCHERER PORTABLE TOOTH POLISHER
K
85
4326
NO FLOSS FLOSSER
K
85
2476
INTERPLAK
K
85
2279
SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201
K
85
0562
FLOSSAGE - ELECTRIC TOOTHFLOSSER
K
82
0537
ULTRASONIC TOOTHBRUSH
K
82
0503
SVENSK TK/2
K
81
0805
WATER PIK AUTOMATIC TOOTHBRUSH
K
81
0666
BRAUN TRAVEL
K
78
0360
MASSAGER, GUM/SSAGE POWERED GUM
K
77
0997
PRO-CARE
K
77
0116
PORTA-PRO TOOTH POLISHER
JES
Floss, Dental
JET
Pick, Massaging
JEW
Tip, Rubber, Oral Hygiene
KCQ
Tube Impression And Matrix
KHR
Absorber, Saliva, Paper
KLC
Chair, Dental, With Operative Unit
KMT
Tray, Fluoride, Disposable
KOJ
Airbrush
KOK
Sterilizer, Endodontic Dry Heat
LCN
Scraper, Tongue
MAU
Eraser, Dental Stain
MCF
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
MMD
Toothbrush, Ionic, Battery-Powered
NOB
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
NRD
Unit, Operative Dental, Accessories
NRU
Chair, Dental, Without Operative Unit
NXV
Diagnostic Light, Soft Tissue Detector
NXZ
Dental Hygiene Kit
PIP
Prophy Powder, Airbrush Accessory
OFX
General Purpose Dental Tray
PFL
Intraoral, Dental Foam Protector
QGO
Composite Resin Warmer
QIA
Powered Tongue Scraper
QJC
Plaque Disclosing Agent
QMJ
Powered Radiofrequency Toothbrush
QNF
Laser Activator For Polymerization
QYJ
Dental Waterline Treatment Cartridge
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-g—miscellaneous-devices
/
JEQ
/
K871406
View Source
THE WOOG ORABRUSH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871406
510(k) Type
Traditional
Applicant
WOOG INTL.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/7/1987
Days to Decision
90 days