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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
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
K
09
1964
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
1
Cleared 510(K)
K
96
4976
FLOSSBRUSH WITH FLUORIDE
1
Cleared 510(K)
K
96
3746
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
1
Cleared 510(K)
K
94
4034
PERIO-MED DENTAL FLOSS
1
Cleared 510(K)
K
95
2091
VUTLER G.U.M. WITH FLUORIDE
1
Cleared 510(K)
K
95
1917
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
1
Cleared 510(K)
K
94
4886
COLGATE PRECISION MINT WZXED DENTAL FLOSS
1
Cleared 510(K)
K
94
3157
ORAL-B ULTRAFLOSS WITH FLLUORIDE
1
Cleared 510(K)
K
94
2689
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE
1
Cleared 510(K)
K
94
2690
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE
1
Cleared 510(K)
K
93
5440
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
1
Cleared 510(K)
K
93
5522
RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE
1
Cleared 510(K)
K
93
1353
FLOSS PLUS
1
Cleared 510(K)
K
92
5409
ORAL-B DENTAL FLOSS WITH FLUORIDE
1
Cleared 510(K)
K
92
5408
ORAL-B DENTAL TAPE WITH FLUORIDE
1
Cleared 510(K)
K
92
1601
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
1
Cleared 510(K)
K
91
4962
FUN FLOSS
1
Cleared 510(K)
K
91
3087
DENTAL FLOSS
1
Cleared 510(K)
K
91
2430
DENTAL FLOSS
1
Cleared 510(K)
K
91
1701
G-FLOSS & G-FLOSS II
1
Cleared 510(K)
K
91
1470
BUFFING FLOSS
1
Cleared 510(K)
K
90
5382
SCRIBBON
1
Cleared 510(K)
K
90
2325
DENTAL CLEANING RINGS
1
Cleared 510(K)
K
90
3712
FLOSSIE TOOTHFLOSS
1
Cleared 510(K)
K
88
5056
TWIXEL(TM)
1
Cleared 510(K)
K
88
4145
FLOSER PLUS
1
Cleared 510(K)
K
88
2571
KOLYNOS DENTAL FLOSS
1
Cleared 510(K)
K
88
3335
COLGATE DENTAL FLOSS
1
Cleared 510(K)
K
88
3024
ORAL-B FLOSSERS
1
Cleared 510(K)
K
88
2828
DENTAL FLOSS PICK
1
Cleared 510(K)
K
88
2164
FLOSS CARD
1
Cleared 510(K)
K
87
4471
SUPER FLOSSER
1
Cleared 510(K)
K
87
1736
CARERITE BIOPACK GINGIVAL RETRACTION CORD
1
Cleared 510(K)
K
87
1393
DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
1
Cleared 510(K)
K
87
1392
DR FLOSSER REFILL
1
Cleared 510(K)
K
87
0996
SEWON DENTAL FLOSSER
1
Cleared 510(K)
K
86
4832
DENTAL FLOSS
1
Cleared 510(K)
K
86
2694
FLOSS CARD
1
Cleared 510(K)
K
86
0963
'E-Z FLOSS' AND 'LAZY FLOSS'
1
Cleared 510(K)
K
86
0769
DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
86
0324
DENTAL FLOSS CARD
1
Cleared 510(K)
K
85
5113
FLOSS HOLDER (PLASTIC)
1
Cleared 510(K)
K
85
4701
RETRACT-A-CORD
1
Cleared 510(K)
K
85
3767
FLOSPIK
1
Cleared 510(K)
K
84
4626
MINI FLOW- DENTAL FLOSS
1
Cleared 510(K)
K
84
4438
SIMPLIFLOS DENTAL FLOSSER
1
Cleared 510(K)
K
84
2846
SEWON DENTAL FLOSS FOLDER
1
Cleared 510(K)
K
84
1675
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE
1
Cleared 510(K)
K
84
0093
DENTAL FLOSSING INSTRUMENT
1
Cleared 510(K)
K
83
1254
DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
83
0225
THE TOOTHPIK
1
Cleared 510(K)
K
82
3278
DENTAL FLOSS TIP
1
Cleared 510(K)
K
82
1685
TOM'S NATURALLY WAXED FLOSSING TAPE
1
Cleared 510(K)
K
82
1155
DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
81
3248
DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
81
2120
GINGI-PLAIN CORDS & BRAIDS
1
Cleared 510(K)
K
81
1926
SE WON(ALUMINUM) DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
81
1555
DENTAL FLOSS HOLDER
1
Cleared 510(K)
K
80
3129
GO-BETWEEN
1
Cleared 510(K)
K
79
2493
GENTLE FLOSS
1
Cleared 510(K)
K
79
1223
DEN-MAT DENTAL FLOSSER
1
Cleared 510(K)
K
76
0571
FLOSS-A-LOT
1
Cleared 510(K)
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
Last synced on 25 January 2026 at 3:41 am
DE
/
subpart-g—miscellaneous-devices
/
JES
/
K840093
View Source
DENTAL FLOSSING INSTRUMENT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K840093
510(k) Type
Traditional
Applicant
LEVERETTE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/5/1984
Days to Decision
86 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
JES
Floss, Dental
K
09
1964
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
K
96
4976
FLOSSBRUSH WITH FLUORIDE
K
96
3746
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
K
94
4034
PERIO-MED DENTAL FLOSS
K
95
2091
VUTLER G.U.M. WITH FLUORIDE
K
95
1917
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
K
94
4886
COLGATE PRECISION MINT WZXED DENTAL FLOSS
K
94
3157
ORAL-B ULTRAFLOSS WITH FLLUORIDE
K
94
2689
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE
K
94
2690
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE
K
93
5440
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
K
93
5522
RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE
K
93
1353
FLOSS PLUS
K
92
5409
ORAL-B DENTAL FLOSS WITH FLUORIDE
K
92
5408
ORAL-B DENTAL TAPE WITH FLUORIDE
K
92
1601
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
K
91
4962
FUN FLOSS
K
91
3087
DENTAL FLOSS
K
91
2430
DENTAL FLOSS
K
91
1701
G-FLOSS & G-FLOSS II
K
91
1470
BUFFING FLOSS
K
90
5382
SCRIBBON
K
90
2325
DENTAL CLEANING RINGS
K
90
3712
FLOSSIE TOOTHFLOSS
K
88
5056
TWIXEL(TM)
K
88
4145
FLOSER PLUS
K
88
2571
KOLYNOS DENTAL FLOSS
K
88
3335
COLGATE DENTAL FLOSS
K
88
3024
ORAL-B FLOSSERS
K
88
2828
DENTAL FLOSS PICK
K
88
2164
FLOSS CARD
K
87
4471
SUPER FLOSSER
K
87
1736
CARERITE BIOPACK GINGIVAL RETRACTION CORD
K
87
1393
DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
K
87
1392
DR FLOSSER REFILL
K
87
0996
SEWON DENTAL FLOSSER
K
86
4832
DENTAL FLOSS
K
86
2694
FLOSS CARD
K
86
0963
'E-Z FLOSS' AND 'LAZY FLOSS'
K
86
0769
DENTAL FLOSS HOLDER
K
86
0324
DENTAL FLOSS CARD
K
85
5113
FLOSS HOLDER (PLASTIC)
K
85
4701
RETRACT-A-CORD
K
85
3767
FLOSPIK
K
84
4626
MINI FLOW- DENTAL FLOSS
K
84
4438
SIMPLIFLOS DENTAL FLOSSER
K
84
2846
SEWON DENTAL FLOSS FOLDER
K
84
1675
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE
K
84
0093
DENTAL FLOSSING INSTRUMENT
K
83
1254
DENTAL FLOSS HOLDER
K
83
0225
THE TOOTHPIK
K
82
3278
DENTAL FLOSS TIP
K
82
1685
TOM'S NATURALLY WAXED FLOSSING TAPE
K
82
1155
DENTAL FLOSS HOLDER
K
81
3248
DENTAL FLOSS HOLDER
K
81
2120
GINGI-PLAIN CORDS & BRAIDS
K
81
1926
SE WON(ALUMINUM) DENTAL FLOSS HOLDER
K
81
1555
DENTAL FLOSS HOLDER
K
80
3129
GO-BETWEEN
K
79
2493
GENTLE FLOSS
K
79
1223
DEN-MAT DENTAL FLOSSER
K
76
0571
FLOSS-A-LOT
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
/
JES
/
K840093
View Source
DENTAL FLOSSING INSTRUMENT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K840093
510(k) Type
Traditional
Applicant
LEVERETTE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/5/1984
Days to Decision
86 days