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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Miscellaneous
LTG
Paste, Injectable For Vocal Cord Augmentation
3
Product Code
LWM
Device, Electrical Dental Anesthesia
U
Product Code
MCL
Kit, Test, In Vitro Periodontal
3
Product Code
MQC
Mouthguard, Prescription
U
Product Code
MVL
Cord, Retraction
U
Product Code
KJJ
Cleanser, Root Canal
U
Product Code
K
24
1354
Sealer Solvent
U
Cleared 510(K)
K
20
1785
EPIEN Dental Cleanser
U
Cleared 510(K)
K
21
1813
Triton
U
Cleared 510(K)
K
19
3357
V-Mix
U
Cleared 510(K)
K
19
3409
Vista Rinse, Vista Rinse Plus
U
Cleared 510(K)
K
20
0330
RC-Prime Root Canal Preparation Cream
U
Cleared 510(K)
K
17
3163
ChlorCid, ChlorCid V, ChlorCid Surf
U
Cleared 510(K)
K
16
2311
Straumann PrefGel
U
Cleared 510(K)
K
16
0577
PacEndo Chlorhexidine
U
Cleared 510(K)
K
15
3528
PacEndo EDTA
U
Cleared 510(K)
K
15
1852
PacEndo Sodium Hyprochlorite
U
Cleared 510(K)
K
15
0020
Irritrol, EDS Combo-Rinse
U
Cleared 510(K)
K
14
1352
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
U
Cleared 510(K)
K
14
0846
EDS COMBO-RINSE
U
Cleared 510(K)
K
13
0180
CLEANSER ROOT CANAL
U
Cleared 510(K)
K
12
3538
EPIEN ROOT CANAL CLEANSER
U
Cleared 510(K)
K
11
2250
CHX=CHX PLUS
U
Cleared 510(K)
K
10
3244
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
U
Cleared 510(K)
K
08
2470
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
U
Cleared 510(K)
K
07
2555
EDTA PLUS
U
Cleared 510(K)
K
07
0401
ENDO-CHX
U
Cleared 510(K)
K
06
3812
STRAUMANN PREFGEL
U
Cleared 510(K)
K
06
3703
CITRIC ACID 20% SOLUTION, MODEL 329
U
Cleared 510(K)
K
06
1689
AQUATINE EC ENDODONTIC CLEANSER
U
Cleared 510(K)
K
06
0335
FILE-EZE
U
Cleared 510(K)
K
05
3167
BIOPURE MTAD ROOT CANAL CLEANSER
U
Cleared 510(K)
K
03
2361
ENDOPURE ROOT CANAL CLEANSER
U
Cleared 510(K)
K
03
2627
ULTRADENT CITRIC ACID 10% SOLUTION
U
Cleared 510(K)
K
03
0884
APTUS BLUE
U
Cleared 510(K)
K
02
4198
SMEARCLEAR
U
Cleared 510(K)
K
00
3422
EDTA ROOT CANAL CLEANSER
U
Cleared 510(K)
K
99
2919
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
U
Cleared 510(K)
K
99
2484
RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG
U
Cleared 510(K)
K
96
2743
PULPDENT SODIUM HYPOCHLORITE SOLUTION
U
Cleared 510(K)
K
95
0365
MOYCO-EDTA
U
Cleared 510(K)
K
93
4415
FILE-EZE
U
Cleared 510(K)
K
92
1713
DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT
U
Cleared 510(K)
K
83
0814
POINT, PAPER ENDODONTIC
U
Cleared 510(K)
K
80
2853
CLEANSER, ROOT CANAL
U
Cleared 510(K)
K
78
0003
ENDOSOLV E
U
Cleared 510(K)
LFD
Saliva, Artificial
U
Product Code
LMW
Solution, Removal, Carries
3
Product Code
LPG
Material, Dressing, Surgical, Polylactic Acid
3
Product Code
LQY
Locator, Root Apex
U
Product Code
NSJ
Restoration, Noble Metal
N
Product Code
NSK
Dentures, Partial
N
Product Code
NSL
Dentures, Full
N
Product Code
NSM
Restoration, Resin
N
Product Code
NSN
Restoration, Resin, Crown And Bridge
N
Product Code
NSO
Restoration, Porcelain-Fused-To-Metal
N
Product Code
NSP
Restoration, Porcelain
N
Product Code
NSQ
Restoration, Base Metal
N
Product Code
NSR
Prosthesis, Orthodontic
N
Product Code
NXJ
Denture, Cosmetic Only
N
Product Code
OBR
Mouthguard, Over-The-Counter
U
Product Code
OCO
Mouthguard, Migraine/Tension Headache
U
Product Code
OLR
Oral Wound Dressing
U
Product Code
OLS
Oral Wound Dressing W/Drug And/Or Biologic
U
Product Code
PKJ
Crown And Bridge Material, Resin Based
N
Product Code
QUA
Intraoral Cooling Device
2
Product Code
SBC
Dental Image Analyzer
2
Product Code
Submissions with No Product Code
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
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
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
DE
/
DE-misc
/
KJJ
/
K150020
View Source
Irritrol, EDS Combo-Rinse
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150020
510(k) Type
Traditional
Applicant
ESSENTIAL DENTAL SYSTESM, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/2015
Days to Decision
50 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
LTG
Paste, Injectable For Vocal Cord Augmentation
LWM
Device, Electrical Dental Anesthesia
MCL
Kit, Test, In Vitro Periodontal
MQC
Mouthguard, Prescription
MVL
Cord, Retraction
KJJ
Cleanser, Root Canal
K
24
1354
Sealer Solvent
K
20
1785
EPIEN Dental Cleanser
K
21
1813
Triton
K
19
3357
V-Mix
K
19
3409
Vista Rinse, Vista Rinse Plus
K
20
0330
RC-Prime Root Canal Preparation Cream
K
17
3163
ChlorCid, ChlorCid V, ChlorCid Surf
K
16
2311
Straumann PrefGel
K
16
0577
PacEndo Chlorhexidine
K
15
3528
PacEndo EDTA
K
15
1852
PacEndo Sodium Hyprochlorite
K
15
0020
Irritrol, EDS Combo-Rinse
K
14
1352
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K
14
0846
EDS COMBO-RINSE
K
13
0180
CLEANSER ROOT CANAL
K
12
3538
EPIEN ROOT CANAL CLEANSER
K
11
2250
CHX=CHX PLUS
K
10
3244
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
K
08
2470
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
K
07
2555
EDTA PLUS
K
07
0401
ENDO-CHX
K
06
3812
STRAUMANN PREFGEL
K
06
3703
CITRIC ACID 20% SOLUTION, MODEL 329
K
06
1689
AQUATINE EC ENDODONTIC CLEANSER
K
06
0335
FILE-EZE
K
05
3167
BIOPURE MTAD ROOT CANAL CLEANSER
K
03
2361
ENDOPURE ROOT CANAL CLEANSER
K
03
2627
ULTRADENT CITRIC ACID 10% SOLUTION
K
03
0884
APTUS BLUE
K
02
4198
SMEARCLEAR
K
00
3422
EDTA ROOT CANAL CLEANSER
K
99
2919
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
K
99
2484
RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG
K
96
2743
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K
95
0365
MOYCO-EDTA
K
93
4415
FILE-EZE
K
92
1713
DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT
K
83
0814
POINT, PAPER ENDODONTIC
K
80
2853
CLEANSER, ROOT CANAL
K
78
0003
ENDOSOLV E
LFD
Saliva, Artificial
LMW
Solution, Removal, Carries
LPG
Material, Dressing, Surgical, Polylactic Acid
LQY
Locator, Root Apex
NSJ
Restoration, Noble Metal
NSK
Dentures, Partial
NSL
Dentures, Full
NSM
Restoration, Resin
NSN
Restoration, Resin, Crown And Bridge
NSO
Restoration, Porcelain-Fused-To-Metal
NSP
Restoration, Porcelain
NSQ
Restoration, Base Metal
NSR
Prosthesis, Orthodontic
NXJ
Denture, Cosmetic Only
OBR
Mouthguard, Over-The-Counter
OCO
Mouthguard, Migraine/Tension Headache
OLR
Oral Wound Dressing
OLS
Oral Wound Dressing W/Drug And/Or Biologic
PKJ
Crown And Bridge Material, Resin Based
QUA
Intraoral Cooling Device
SBC
Dental Image Analyzer
Submissions with No Product Code
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
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
/
DE-misc
/
KJJ
/
K150020
View Source
Irritrol, EDS Combo-Rinse
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150020
510(k) Type
Traditional
Applicant
ESSENTIAL DENTAL SYSTESM, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/2015
Days to Decision
50 days
Submission Type
Summary