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Review Panel
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Review Panel
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Review Panel
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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
K
13
0186
DENTEK EASY BRUSH WITH FLUORIDE
1
Cleared 510(K)
K
12
1165
BEAM BRUSH/BEAM APP
1
Cleared 510(K)
K
10
2871
SILVER CARE ANITBACTERIAL TOOTHBRUSH
1
Cleared 510(K)
K
07
3224
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
1
Cleared 510(K)
K
02
1383
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
1
Cleared 510(K)
K
02
0776
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
1
Cleared 510(K)
K
00
0290
LAZERSMILE, LAZERWHITE
1
Cleared 510(K)
K
99
4144
TOOTHBRUSH WASH
1
Cleared 510(K)
K
99
2435
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
1
Cleared 510(K)
K
98
0995
PLAQ-ATAQ-I
1
Cleared 510(K)
K
97
4761
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
1
Cleared 510(K)
K
97
3236
CREST TOOTHBRUSH WITH MICROSHIELD
1
Cleared 510(K)
K
97
1589
REACH ANTIBACTERIAL TOOTHBRUSH
1
Cleared 510(K)
K
95
5530
RANIR HI-TECHNOLOGY DENTAL FLOSS
1
Cleared 510(K)
K
95
0993
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
1
Cleared 510(K)
K
93
0869
ECO TOOTHBRUSH
1
Cleared 510(K)
K
90
5090
FEEL FRESH TOOTHBRUSH KIT
1
Cleared 510(K)
K
90
1994
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
1
Cleared 510(K)
K
89
2264
ORALCHEK SUPER-SOFT BRUSH
1
Cleared 510(K)
K
88
2572
DOCTOR KOLYNOS TOOTHBRUSH
1
Cleared 510(K)
K
89
0812
HEADS TRUE BRUSH
1
Cleared 510(K)
K
88
3761
IONODENT II (6 VOLTS)
1
Cleared 510(K)
K
87
4443
IONODENT (TOOTHBRUSH)
1
Cleared 510(K)
K
88
0485
XENEX DENTAL ROULETTE
1
Cleared 510(K)
K
87
3317
EZ BRUSH & FLOSS
1
Cleared 510(K)
K
87
1879
SOFSWAB
1
Cleared 510(K)
K
87
0414
QUIK-BRUSH
1
Cleared 510(K)
K
87
1359
CHECK-MATE AND CHECK-MATE [+]
1
Cleared 510(K)
K
87
0906
CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500
1
Cleared 510(K)
K
86
4455
THE EXPERIMENTAL
1
Cleared 510(K)
K
85
2691
ODONTO TOOTHBRUSH
1
Cleared 510(K)
K
85
2400
PLAK SMACKER
1
Cleared 510(K)
K
83
4580
REACH* TOOTHBRUSH
1
Cleared 510(K)
K
83
3815
ZACT DENTAL ARCH TOOTHBRUSCH
1
Cleared 510(K)
K
81
2363
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED
1
Cleared 510(K)
K
81
2364
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
1
Cleared 510(K)
K
81
2362
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
1
Cleared 510(K)
K
81
2361
PORTABLE TOOTHBRUSH KIT (NO SAMPLE)
1
Cleared 510(K)
K
80
0831
PY-CO-PROX TM DENTAL BRUSH
1
Cleared 510(K)
K
80
0154
TOTE-BRUSH
1
Cleared 510(K)
K
78
1962
DIJI-DENT
1
Cleared 510(K)
K
78
1018
DX TOOTHBRUSH
1
Cleared 510(K)
K
77
1184
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
1
Cleared 510(K)
K
77
1185
PERIODONTIC TOOTHBRUSH, #0126-0190-00
1
Cleared 510(K)
K
77
1183
TOOTHBRUSH, PEDODONTIC, #0126-0188-00
1
Cleared 510(K)
K
77
0749
TOOTHBRUSH, REACH
1
Cleared 510(K)
K
77
0464
TOOTHBRUSH, PLAK-A-DENT
1
Cleared 510(K)
K
76
1352
DENTAL STAIN REMOVER
1
Cleared 510(K)
K
76
0512
TOOTHBRUSH
1
Cleared 510(K)
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
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
Review Panel
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Review Panel
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Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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
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Review Panel
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Review Panel
Last synced on 25 January 2026 at 3:41 am
DE
/
subpart-g—miscellaneous-devices
/
EFW
/
K974761
View Source
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K974761
510(k) Type
Traditional
Applicant
John O. Butler Co.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/1998
Days to Decision
179 days
Submission Type
Statement
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
K
13
0186
DENTEK EASY BRUSH WITH FLUORIDE
K
12
1165
BEAM BRUSH/BEAM APP
K
10
2871
SILVER CARE ANITBACTERIAL TOOTHBRUSH
K
07
3224
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K
02
1383
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
K
02
0776
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K
00
0290
LAZERSMILE, LAZERWHITE
K
99
4144
TOOTHBRUSH WASH
K
99
2435
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K
98
0995
PLAQ-ATAQ-I
K
97
4761
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
K
97
3236
CREST TOOTHBRUSH WITH MICROSHIELD
K
97
1589
REACH ANTIBACTERIAL TOOTHBRUSH
K
95
5530
RANIR HI-TECHNOLOGY DENTAL FLOSS
K
95
0993
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
K
93
0869
ECO TOOTHBRUSH
K
90
5090
FEEL FRESH TOOTHBRUSH KIT
K
90
1994
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
K
89
2264
ORALCHEK SUPER-SOFT BRUSH
K
88
2572
DOCTOR KOLYNOS TOOTHBRUSH
K
89
0812
HEADS TRUE BRUSH
K
88
3761
IONODENT II (6 VOLTS)
K
87
4443
IONODENT (TOOTHBRUSH)
K
88
0485
XENEX DENTAL ROULETTE
K
87
3317
EZ BRUSH & FLOSS
K
87
1879
SOFSWAB
K
87
0414
QUIK-BRUSH
K
87
1359
CHECK-MATE AND CHECK-MATE [+]
K
87
0906
CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500
K
86
4455
THE EXPERIMENTAL
K
85
2691
ODONTO TOOTHBRUSH
K
85
2400
PLAK SMACKER
K
83
4580
REACH* TOOTHBRUSH
K
83
3815
ZACT DENTAL ARCH TOOTHBRUSCH
K
81
2363
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED
K
81
2364
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
K
81
2362
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
K
81
2361
PORTABLE TOOTHBRUSH KIT (NO SAMPLE)
K
80
0831
PY-CO-PROX TM DENTAL BRUSH
K
80
0154
TOTE-BRUSH
K
78
1962
DIJI-DENT
K
78
1018
DX TOOTHBRUSH
K
77
1184
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
K
77
1185
PERIODONTIC TOOTHBRUSH, #0126-0190-00
K
77
1183
TOOTHBRUSH, PEDODONTIC, #0126-0188-00
K
77
0749
TOOTHBRUSH, REACH
K
77
0464
TOOTHBRUSH, PLAK-A-DENT
K
76
1352
DENTAL STAIN REMOVER
K
76
0512
TOOTHBRUSH
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
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
/
EFW
/
K974761
View Source
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K974761
510(k) Type
Traditional
Applicant
John O. Butler Co.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/1998
Days to Decision
179 days
Submission Type
Statement