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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
K
24
0463
Slow Wave DS8 (SWDS802)
U
Cleared 510(K)
K
23
1793
RODIN 3D Resin SPLINT, Hard/Flex
U
Cleared 510(K)
K
23
2087
Dental LT Comfort Resin
U
Cleared 510(K)
K
23
0548
Myoaligner Appliance
U
Cleared 510(K)
K
23
0592
LuxCreo Dental Night Guard Resin
U
Cleared 510(K)
K
22
2845
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
U
Cleared 510(K)
K
23
0495
Serena Sleep Night Guard
U
Cleared 510(K)
K
23
2448
FREEPRINT® splintmaster
U
Cleared 510(K)
K
23
0237
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
U
Cleared 510(K)
K
22
2604
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
U
Cleared 510(K)
Show All 63 Submissions
MVL
Cord, Retraction
U
Product Code
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
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Subpart G—Miscellaneous Devices
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Ear, Nose, Throat
Review Panel
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Review Panel
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Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
DE
/
DE-misc
/
MQC
/
K240463
View Source
Slow Wave DS8 (SWDS802)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240463
510(k) Type
Traditional
Applicant
Slow Wave Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/2024
Days to Decision
109 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
K
24
0463
Slow Wave DS8 (SWDS802)
K
23
1793
RODIN 3D Resin SPLINT, Hard/Flex
K
23
2087
Dental LT Comfort Resin
K
23
0548
Myoaligner Appliance
K
23
0592
LuxCreo Dental Night Guard Resin
K
22
2845
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K
23
0495
Serena Sleep Night Guard
K
23
2448
FREEPRINT® splintmaster
K
23
0237
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
K
22
2604
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
Show All 63 Submissions
MVL
Cord, Retraction
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
/
MQC
/
K240463
View Source
Slow Wave DS8 (SWDS802)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240463
510(k) Type
Traditional
Applicant
Slow Wave Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/2024
Days to Decision
109 days
Submission Type
Summary