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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
K
21
1420
Stasis Gel
U
Cleared 510(K)
K
21
1419
Gingi-Aid Gel
U
Cleared 510(K)
K
21
3149
VOCO Retraction Paste
U
Cleared 510(K)
K
20
0764
STATSTIX
U
Cleared 510(K)
K
19
3389
Vista Clear
U
Cleared 510(K)
K
19
0220
Vista FS, Vista FS Liquid
U
Cleared 510(K)
K
17
1577
Smartcord, Smartcord X
U
Cleared 510(K)
K
16
2662
GingiDent Gingival Retraction Paste
U
Cleared 510(K)
K
16
2948
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
U
Cleared 510(K)
K
16
2536
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
U
Cleared 510(K)
K
16
2164
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
U
Cleared 510(K)
K
15
2064
Astringedent Clear
U
Cleared 510(K)
K
15
0423
EXPAZEN
U
Cleared 510(K)
K
13
0580
RETRACTION PASTE
U
Cleared 510(K)
K
13
1799
QUICKNIT
U
Cleared 510(K)
K
13
2526
KNIT-PAK+
U
Cleared 510(K)
K
12
3215
VISCOSTAT CLEAR
U
Cleared 510(K)
K
11
3839
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
U
Cleared 510(K)
K
11
1978
SULCUS BLUE
U
Cleared 510(K)
K
11
1348
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
U
Cleared 510(K)
K
10
1756
TSC
U
Cleared 510(K)
K
10
2133
GIRAFFE2
U
Cleared 510(K)
K
09
3721
COSP2
U
Cleared 510(K)
K
09
3711
RACEGEL
U
Cleared 510(K)
K
09
2384
LIQUICORD
U
Cleared 510(K)
K
09
1380
CORDCAP
U
Cleared 510(K)
K
08
3695
TRAXODENT
U
Cleared 510(K)
K
08
2116
HEMOSTASYL PASTE
U
Cleared 510(K)
K
05
3329
KORLEX-GR GINGIVAL RETRACTION PASTE
U
Cleared 510(K)
K
05
0180
EXPA-SYL
U
Cleared 510(K)
K
04
1023
STAY-PUT IMPREGNATED
U
Cleared 510(K)
K
01
0070
ULTRAPAK NEHA
U
Cleared 510(K)
K
98
1596
ULTRAPAK E
U
Cleared 510(K)
QMJ
Powered Radiofrequency Toothbrush
2
Product Code
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
2
Product Code
KJJ
Cleanser, Root Canal
U
Product Code
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 16 August 2024 at 11:05 pm
DE
/
DE-misc
/
MVL
/
K113839
View Source
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113839
510(k) Type
Traditional
Applicant
PARKELL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/12/2012
Days to Decision
106 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
K
21
1420
Stasis Gel
K
21
1419
Gingi-Aid Gel
K
21
3149
VOCO Retraction Paste
K
20
0764
STATSTIX
K
19
3389
Vista Clear
K
19
0220
Vista FS, Vista FS Liquid
K
17
1577
Smartcord, Smartcord X
K
16
2662
GingiDent Gingival Retraction Paste
K
16
2948
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
K
16
2536
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
K
16
2164
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
K
15
2064
Astringedent Clear
K
15
0423
EXPAZEN
K
13
0580
RETRACTION PASTE
K
13
1799
QUICKNIT
K
13
2526
KNIT-PAK+
K
12
3215
VISCOSTAT CLEAR
K
11
3839
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K
11
1978
SULCUS BLUE
K
11
1348
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K
10
1756
TSC
K
10
2133
GIRAFFE2
K
09
3721
COSP2
K
09
3711
RACEGEL
K
09
2384
LIQUICORD
K
09
1380
CORDCAP
K
08
3695
TRAXODENT
K
08
2116
HEMOSTASYL PASTE
K
05
3329
KORLEX-GR GINGIVAL RETRACTION PASTE
K
05
0180
EXPA-SYL
K
04
1023
STAY-PUT IMPREGNATED
K
01
0070
ULTRAPAK NEHA
K
98
1596
ULTRAPAK E
QMJ
Powered Radiofrequency Toothbrush
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
KJJ
Cleanser, Root Canal
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
/
MVL
/
K113839
View Source
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113839
510(k) Type
Traditional
Applicant
PARKELL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/12/2012
Days to Decision
106 days
Submission Type
Summary