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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
K
02
3232
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
1
Cleared 510(K)
K
00
1493
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
1
Cleared 510(K)
K
98
3374
AGATHA-A-H2010
1
Cleared 510(K)
K
96
4810
DERMADAM
1
Cleared 510(K)
K
95
2234
BARRIER ALL FILM
1
Cleared 510(K)
K
94
3182
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
1
Cleared 510(K)
K
92
3711
PERIOFLEX TIP
1
Cleared 510(K)
K
92
3937
HYDRO FLOSS
1
Cleared 510(K)
K
93
1380
WATER PIK PLUS PLAQUE CONTROL SYSTEM
1
Cleared 510(K)
K
92
3457
SHOWERFLOSS
1
Cleared 510(K)
K
92
2307
SHOWERFLOSS ORAL IRRIGATION UNIT
1
Cleared 510(K)
K
92
1999
INTERJET(TM) GINGIVAL CARE INSTRUMENT
1
Cleared 510(K)
K
91
3030
MAX-I-PROBE IRRIGATION SYSTEM
1
Cleared 510(K)
K
91
0832
OXYFRESH OXYCARE 3000
1
Cleared 510(K)
K
90
1955
PERIOGARD(R) PERIOPEN
1
Cleared 510(K)
K
90
5188
PERIO PIK
1
Cleared 510(K)
K
90
4850
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
1
Cleared 510(K)
K
89
7053
L'LL SQUIRT GUM ORAL RINSE DEVICE
1
Cleared 510(K)
K
90
1600
OSSEOTITE IRRIGATION UNIT
1
Cleared 510(K)
K
90
0547
WATER PIK(R) W/ADD'L CLAIMS
1
Cleared 510(K)
K
90
0178
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
1
Cleared 510(K)
K
90
0991
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
1
Cleared 510(K)
K
89
6890
DYNASURG DENTAL IRRIGATION SYSTEM
1
Cleared 510(K)
K
89
5259
PIK POCKET(R), MODEL PP-3
1
Cleared 510(K)
K
89
4015
WATER PIK(R)
1
Cleared 510(K)
K
89
0600
HYDRODENT ANTIPLAQUE SYSTEM
1
Cleared 510(K)
K
88
4220
AIR WATER SYRINGE TIP SHIELD
1
Cleared 510(K)
K
88
2759
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
1
Cleared 510(K)
K
87
5132
PERIODONTAL SCALING SOLUTION-A
1
Cleared 510(K)
K
87
5150
PERIODONTAL SCALING SOLUTION-C
1
Cleared 510(K)
K
87
5149
PERIDONTAL SCALING SOLUTION-B
1
Cleared 510(K)
K
86
4540
PLAK VAK - PV-10
1
Cleared 510(K)
K
86
3131
PIK POCKET (IRRIGATING TIP)
1
Cleared 510(K)
K
85
2593
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
1
Cleared 510(K)
K
84
4339
BRAUN DENTAL CENTER OC-3
1
Cleared 510(K)
K
84
4318
ORAL IRRIGATION TIP
1
Cleared 510(K)
K
84
0721
PERIO PIK
1
Cleared 510(K)
K
83
4545
POCKETIP 4414
1
Cleared 510(K)
K
83
2222
PRO PULSE PERIODONTAL IRRIGATOR 7618
1
Cleared 510(K)
K
83
2223
PERIODONTAL IRRIGATOR #7620
1
Cleared 510(K)
K
83
1321
GUM MACHINE
1
Cleared 510(K)
K
82
3305
DENTO SPRAY ORAL IRRIGATOR
1
Cleared 510(K)
K
81
3638
MULTI-UNIT, MULTI-PURPOSE DEVICE
1
Cleared 510(K)
K
81
1175
RECOH ROOT CANAL IRRIGATOR
1
Cleared 510(K)
K
81
0864
WATER PIK ORAL HYGIENE CENTER
1
Cleared 510(K)
K
80
2595
ERGO IRRIGATION SYSTEM
1
Cleared 510(K)
K
80
0448
WATER PIK TRAVELER, MODEL 79
1
Cleared 510(K)
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
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
Gastroenterology and Urology
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
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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 6 June 2025 at 11:06 pm
DE
/
subpart-g—miscellaneous-devices
/
EFS
/
K875150
View Source
PERIODONTAL SCALING SOLUTION-C
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875150
510(k) Type
Traditional
Applicant
DENTSPLY INTL.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/1988
Days to Decision
70 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
K
02
3232
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
K
00
1493
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K
98
3374
AGATHA-A-H2010
K
96
4810
DERMADAM
K
95
2234
BARRIER ALL FILM
K
94
3182
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K
92
3711
PERIOFLEX TIP
K
92
3937
HYDRO FLOSS
K
93
1380
WATER PIK PLUS PLAQUE CONTROL SYSTEM
K
92
3457
SHOWERFLOSS
K
92
2307
SHOWERFLOSS ORAL IRRIGATION UNIT
K
92
1999
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K
91
3030
MAX-I-PROBE IRRIGATION SYSTEM
K
91
0832
OXYFRESH OXYCARE 3000
K
90
1955
PERIOGARD(R) PERIOPEN
K
90
5188
PERIO PIK
K
90
4850
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
K
89
7053
L'LL SQUIRT GUM ORAL RINSE DEVICE
K
90
1600
OSSEOTITE IRRIGATION UNIT
K
90
0547
WATER PIK(R) W/ADD'L CLAIMS
K
90
0178
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K
90
0991
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K
89
6890
DYNASURG DENTAL IRRIGATION SYSTEM
K
89
5259
PIK POCKET(R), MODEL PP-3
K
89
4015
WATER PIK(R)
K
89
0600
HYDRODENT ANTIPLAQUE SYSTEM
K
88
4220
AIR WATER SYRINGE TIP SHIELD
K
88
2759
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
K
87
5132
PERIODONTAL SCALING SOLUTION-A
K
87
5150
PERIODONTAL SCALING SOLUTION-C
K
87
5149
PERIDONTAL SCALING SOLUTION-B
K
86
4540
PLAK VAK - PV-10
K
86
3131
PIK POCKET (IRRIGATING TIP)
K
85
2593
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
K
84
4339
BRAUN DENTAL CENTER OC-3
K
84
4318
ORAL IRRIGATION TIP
K
84
0721
PERIO PIK
K
83
4545
POCKETIP 4414
K
83
2222
PRO PULSE PERIODONTAL IRRIGATOR 7618
K
83
2223
PERIODONTAL IRRIGATOR #7620
K
83
1321
GUM MACHINE
K
82
3305
DENTO SPRAY ORAL IRRIGATOR
K
81
3638
MULTI-UNIT, MULTI-PURPOSE DEVICE
K
81
1175
RECOH ROOT CANAL IRRIGATOR
K
81
0864
WATER PIK ORAL HYGIENE CENTER
K
80
2595
ERGO IRRIGATION SYSTEM
K
80
0448
WATER PIK TRAVELER, MODEL 79
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
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
/
EFS
/
K875150
View Source
PERIODONTAL SCALING SOLUTION-C
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875150
510(k) Type
Traditional
Applicant
DENTSPLY INTL.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/1988
Days to Decision
70 days