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Innolitics
Anesthesiology
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
LFD
Saliva, Artificial
U
Product Code
K
24
0508
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
U
Cleared 510(K)
K
23
4015
Caphosol® Artifical Saliva (32 doses sachet box)
U
Cleared 510(K)
K
23
1205
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
U
Cleared 510(K)
K
20
2689
Dentilube Spray
U
Cleared 510(K)
K
20
3567
Oral-B Dry Mouth Oral Rinse
U
Cleared 510(K)
K
20
1277
Oral-B Dry Mouth Oral Rinse
U
Cleared 510(K)
K
18
1839
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
U
Cleared 510(K)
K
19
0144
MucoPEG
U
Cleared 510(K)
K
18
1194
SmartMouth DryMouth Oral Rinse
U
Cleared 510(K)
K
18
0680
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
U
Cleared 510(K)
K
17
3808
Voutia™
U
Cleared 510(K)
K
18
1134
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
U
Cleared 510(K)
K
17
3237
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
U
Cleared 510(K)
K
17
1542
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
U
Cleared 510(K)
K
16
3029
Hydris™ Oral Rinse
U
Cleared 510(K)
K
16
3476
Lubricity
U
Cleared 510(K)
K
16
2167
Caphosol Artifical Saliva Tablets
U
Cleared 510(K)
K
15
2201
MedActive Oral Gel and Spray
U
Cleared 510(K)
K
15
2406
SalivaMAX
U
Cleared 510(K)
K
14
2657
XEROSTOM SALIVA SUBSTITUTE GEL
U
Cleared 510(K)
K
15
0074
Elevate Moisturizing Spray
U
Cleared 510(K)
K
14
2549
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
U
Cleared 510(K)
K
12
2663
ORAMOIST
U
Cleared 510(K)
K
12
3731
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
U
Cleared 510(K)
K
12
0552
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
U
Cleared 510(K)
K
11
1250
DRY MOUTH MOUTHWASH
U
Cleared 510(K)
K
10
3745
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
U
Cleared 510(K)
K
11
0116
XEROS DRY MOUTH PUMP
U
Cleared 510(K)
K
10
1346
GC ORAL MOISTURIZING GEL
U
Cleared 510(K)
K
10
1477
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
U
Cleared 510(K)
K
09
3642
NEUTRASAL
U
Cleared 510(K)
K
09
1718
NEUTRASAL
U
Cleared 510(K)
K
09
1419
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
U
Cleared 510(K)
K
07
2306
BIOXTRA MOISTURIZING GEL
U
Cleared 510(K)
K
07
1617
ORAL NEUTRALIZER
U
Cleared 510(K)
K
06
2653
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
U
Cleared 510(K)
K
06
1331
ORAL BALANCE LIQUID/ GEL
U
Cleared 510(K)
K
05
1812
TGO SPRAY
U
Cleared 510(K)
K
04
1563
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
U
Cleared 510(K)
K
03
0802
CAPHOSOL
U
Cleared 510(K)
K
02
4148
SALINUM, ORCLAIR
U
Cleared 510(K)
K
98
1693
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
U
Cleared 510(K)
K
99
1938
CAPHOSOL ARTIFICIAL SALIVA
U
Cleared 510(K)
K
87
4106
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
U
Cleared 510(K)
K
85
1026
MOI-STIR ORAL SWABSTICK(S)
U
Cleared 510(K)
K
84
0807
THROAT MOI-STIR
U
Cleared 510(K)
K
82
2971
SALIVA SUBSTITUTE
U
Cleared 510(K)
K
81
0157
MOI-STIR
U
Cleared 510(K)
P
79
0016
SALIVART
U
PMA Approval
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
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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
/
DE-misc
/
LFD
/
K163476
View Source
Lubricity
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163476
510(k) Type
Traditional
Applicant
You First Services, Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/10/2017
Days to Decision
149 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
LFD
Saliva, Artificial
K
24
0508
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K
23
4015
Caphosol® Artifical Saliva (32 doses sachet box)
K
23
1205
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K
20
2689
Dentilube Spray
K
20
3567
Oral-B Dry Mouth Oral Rinse
K
20
1277
Oral-B Dry Mouth Oral Rinse
K
18
1839
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K
19
0144
MucoPEG
K
18
1194
SmartMouth DryMouth Oral Rinse
K
18
0680
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
K
17
3808
Voutia™
K
18
1134
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
K
17
3237
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K
17
1542
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K
16
3029
Hydris™ Oral Rinse
K
16
3476
Lubricity
K
16
2167
Caphosol Artifical Saliva Tablets
K
15
2201
MedActive Oral Gel and Spray
K
15
2406
SalivaMAX
K
14
2657
XEROSTOM SALIVA SUBSTITUTE GEL
K
15
0074
Elevate Moisturizing Spray
K
14
2549
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
K
12
2663
ORAMOIST
K
12
3731
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
K
12
0552
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K
11
1250
DRY MOUTH MOUTHWASH
K
10
3745
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K
11
0116
XEROS DRY MOUTH PUMP
K
10
1346
GC ORAL MOISTURIZING GEL
K
10
1477
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K
09
3642
NEUTRASAL
K
09
1718
NEUTRASAL
K
09
1419
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
K
07
2306
BIOXTRA MOISTURIZING GEL
K
07
1617
ORAL NEUTRALIZER
K
06
2653
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
K
06
1331
ORAL BALANCE LIQUID/ GEL
K
05
1812
TGO SPRAY
K
04
1563
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K
03
0802
CAPHOSOL
K
02
4148
SALINUM, ORCLAIR
K
98
1693
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
K
99
1938
CAPHOSOL ARTIFICIAL SALIVA
K
87
4106
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K
85
1026
MOI-STIR ORAL SWABSTICK(S)
K
84
0807
THROAT MOI-STIR
K
82
2971
SALIVA SUBSTITUTE
K
81
0157
MOI-STIR
P
79
0016
SALIVART
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
/
LFD
/
K163476
View Source
Lubricity
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163476
510(k) Type
Traditional
Applicant
You First Services, Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/10/2017
Days to Decision
149 days
Submission Type
Summary