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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
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
K
96
3747
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
1
Cleared 510(K)
K
94
2633
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
1
Cleared 510(K)
K
93
0178
ELECTRO FLOSS
1
Cleared 510(K)
K
91
1418
GUM MASSAGER
1
Cleared 510(K)
K
88
5189
MASSAGING PICK FOR ORAL HYGIENE
1
Cleared 510(K)
K
89
0910
PLAKOF
1
Cleared 510(K)
K
88
3225
FLOSSIE
1
Cleared 510(K)
K
88
1900
PERMA-PIC PLASTIC TOOTHPICK
1
Cleared 510(K)
K
88
1046
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE
1
Cleared 510(K)
K
86
0779
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH
1
Cleared 510(K)
K
85
0775
DENTAL MASSAGING PICKS
1
Cleared 510(K)
K
84
4238
ORAPIK PERIODONTAL SCALER
1
Cleared 510(K)
K
83
2949
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN
1
Cleared 510(K)
K
82
1629
FIXIDENT
1
Cleared 510(K)
K
82
0979
RESILIENT GUM EXERCISER
1
Cleared 510(K)
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
General Hospital
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
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
DE
/
subpart-g—miscellaneous-devices
/
JET
/
K820979
View Source
RESILIENT GUM EXERCISER
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K820979
510(k) Type
Traditional
Applicant
MARTIN A. HASS, D.D.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/10/1982
Days to Decision
34 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
JET
Pick, Massaging
K
96
3747
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
K
94
2633
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
K
93
0178
ELECTRO FLOSS
K
91
1418
GUM MASSAGER
K
88
5189
MASSAGING PICK FOR ORAL HYGIENE
K
89
0910
PLAKOF
K
88
3225
FLOSSIE
K
88
1900
PERMA-PIC PLASTIC TOOTHPICK
K
88
1046
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE
K
86
0779
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH
K
85
0775
DENTAL MASSAGING PICKS
K
84
4238
ORAPIK PERIODONTAL SCALER
K
83
2949
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN
K
82
1629
FIXIDENT
K
82
0979
RESILIENT GUM EXERCISER
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
/
JET
/
K820979
View Source
RESILIENT GUM EXERCISER
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K820979
510(k) Type
Traditional
Applicant
MARTIN A. HASS, D.D.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/10/1982
Days to Decision
34 days