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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
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
K
06
3236
BETA-POWDER
2
Cleared 510(K)
K
04
2872
RONDOFLEX PLUS 360
2
Cleared 510(K)
K
03
3675
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
2
Cleared 510(K)
K
03
3215
PREPAIR
2
Cleared 510(K)
K
02
4105
VELOPEX AQUACUT FLUID ABRASION UNIT
2
Cleared 510(K)
K
03
0292
GROMAN PREPMASTER
2
Cleared 510(K)
K
02
1450
CLINPRO PROPHY POWDER
2
Cleared 510(K)
K
01
4188
NEW PROPHY POWDER
2
Cleared 510(K)
K
01
4249
JETPOLISHER
2
Cleared 510(K)
K
01
4252
JETSTREAM
2
Cleared 510(K)
K
01
4245
JETSONIC 2000
2
Cleared 510(K)
K
01
3969
MINIBLASTER
2
Cleared 510(K)
K
99
3182
DISPOPROPHY
2
Cleared 510(K)
K
99
3124
DISPODRILL
2
Cleared 510(K)
K
98
4380
DISPO ETCH
2
Cleared 510(K)
K
01
0816
DENTO-PREP PARTICLE MICROBLASTER
2
Cleared 510(K)
K
00
2708
KAVO CORUND HANDPIECE 2013
2
Cleared 510(K)
K
99
0060
MACH 7
2
Cleared 510(K)
K
00
1313
AIRDENT II CS
2
Cleared 510(K)
K
98
0672
SIMPLEX AIRBRATOR (SAB-7)
2
Cleared 510(K)
K
98
4415
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
2
Cleared 510(K)
K
99
0545
JETSONIC 2000
2
Cleared 510(K)
K
98
1564
AIR TECHNIQUES' AIRDENT II
2
Cleared 510(K)
K
97
4655
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
2
Cleared 510(K)
K
98
0216
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
2
Cleared 510(K)
K
97
4488
AIRPREP SYSTEM - MODEL 9001
2
Cleared 510(K)
K
98
0726
ULTRA-BLASTER
2
Cleared 510(K)
K
97
3679
AEROETCHER
2
Cleared 510(K)
K
97
0589
MICROETCHER AP
2
Cleared 510(K)
K
96
4755
MICROJET CAVITY PREPARATION SYSTEM
2
Cleared 510(K)
K
97
0484
ACCU-PREP
2
Cleared 510(K)
K
97
0249
SIMPLEX AIRBRATOR
2
Cleared 510(K)
K
96
4145
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
2
Cleared 510(K)
K
96
4059
MICADENT
2
Cleared 510(K)
K
95
5573
OPTIBLAST INTRAORAL SANDBLASTER
2
Cleared 510(K)
K
95
5050
JETSTREAM CAVITY PREPARATION SYSTEM
2
Cleared 510(K)
K
93
1845
SANDBLASTER
2
Cleared 510(K)
K
94
0776
KREATIV MODEL KV-1
2
Cleared 510(K)
K
93
2997
MICROPREP CAVITY PREPERATION SYSTEM
2
Cleared 510(K)
K
92
1748
MODEL 2000 DENTAL AIR ABRASIVE SYSTEM
2
Cleared 510(K)
K
90
3284
YOUNG PROPHY SYSTEM, PS UNIT
2
Cleared 510(K)
K
90
2836
MICROETCHER
2
Cleared 510(K)
K
87
5340
JETPOLISHER(TM)
2
Cleared 510(K)
K
87
1980
D-23 DENTURE ADHESIVE
2
Cleared 510(K)
K
86
2384
SCHEIN AP-1 AIR POLISHING UNIT
2
Cleared 510(K)
K
85
2521
SATLEC PROPHY UNIT PU 3055
2
Cleared 510(K)
K
84
0720
FIBER HEMOFILTERS FH55-FH77 & 88
2
Cleared 510(K)
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
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Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
DE
/
subpart-g—miscellaneous-devices
/
KOJ
/
K980672
View Source
SIMPLEX AIRBRATOR (SAB-7)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980672
510(k) Type
Traditional
Applicant
IRT MANAGEMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2000
Days to Decision
804 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
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
K
06
3236
BETA-POWDER
K
04
2872
RONDOFLEX PLUS 360
K
03
3675
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K
03
3215
PREPAIR
K
02
4105
VELOPEX AQUACUT FLUID ABRASION UNIT
K
03
0292
GROMAN PREPMASTER
K
02
1450
CLINPRO PROPHY POWDER
K
01
4188
NEW PROPHY POWDER
K
01
4249
JETPOLISHER
K
01
4252
JETSTREAM
K
01
4245
JETSONIC 2000
K
01
3969
MINIBLASTER
K
99
3182
DISPOPROPHY
K
99
3124
DISPODRILL
K
98
4380
DISPO ETCH
K
01
0816
DENTO-PREP PARTICLE MICROBLASTER
K
00
2708
KAVO CORUND HANDPIECE 2013
K
99
0060
MACH 7
K
00
1313
AIRDENT II CS
K
98
0672
SIMPLEX AIRBRATOR (SAB-7)
K
98
4415
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
K
99
0545
JETSONIC 2000
K
98
1564
AIR TECHNIQUES' AIRDENT II
K
97
4655
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
K
98
0216
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
K
97
4488
AIRPREP SYSTEM - MODEL 9001
K
98
0726
ULTRA-BLASTER
K
97
3679
AEROETCHER
K
97
0589
MICROETCHER AP
K
96
4755
MICROJET CAVITY PREPARATION SYSTEM
K
97
0484
ACCU-PREP
K
97
0249
SIMPLEX AIRBRATOR
K
96
4145
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
K
96
4059
MICADENT
K
95
5573
OPTIBLAST INTRAORAL SANDBLASTER
K
95
5050
JETSTREAM CAVITY PREPARATION SYSTEM
K
93
1845
SANDBLASTER
K
94
0776
KREATIV MODEL KV-1
K
93
2997
MICROPREP CAVITY PREPERATION SYSTEM
K
92
1748
MODEL 2000 DENTAL AIR ABRASIVE SYSTEM
K
90
3284
YOUNG PROPHY SYSTEM, PS UNIT
K
90
2836
MICROETCHER
K
87
5340
JETPOLISHER(TM)
K
87
1980
D-23 DENTURE ADHESIVE
K
86
2384
SCHEIN AP-1 AIR POLISHING UNIT
K
85
2521
SATLEC PROPHY UNIT PU 3055
K
84
0720
FIBER HEMOFILTERS FH55-FH77 & 88
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
/
KOJ
/
K980672
View Source
SIMPLEX AIRBRATOR (SAB-7)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980672
510(k) Type
Traditional
Applicant
IRT MANAGEMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2000
Days to Decision
804 days
Submission Type
Statement