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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)
Show All 49 Submissions
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
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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
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Medical Genetics
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Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
DE
/
DE-misc
/
LFD
/
K240508
View Source
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240508
510(k) Type
Traditional
Applicant
Laclede, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/19/2024
Days to Decision
58 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
Show All 49 Submissions
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
/
K240508
View Source
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240508
510(k) Type
Traditional
Applicant
Laclede, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/19/2024
Days to Decision
58 days
Submission Type
Summary