FDA Browser
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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
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
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
K
24
0810
Anti Grinding Guard
U
Cleared 510(K)
K
23
2238
Goyo Mouthpiece S
U
Cleared 510(K)
K
23
1865
Mouth Guard (ATG0603R)
U
Cleared 510(K)
K
22
1369
FBCC Night Guard
U
Cleared 510(K)
K
22
2424
Protect-It Custom Fit Dental Guard
U
Cleared 510(K)
K
21
2706
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
U
Cleared 510(K)
K
21
1158
NTI ClenchGuard
U
Cleared 510(K)
K
20
2974
DenTek Fresh Protect Dental Guard
U
Cleared 510(K)
K
19
3577
SleepRight ProRx Custom Dental Guard
U
Cleared 510(K)
K
18
1005
ClenchGuard
U
Cleared 510(K)
Show All 40 Submissions
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
/
OBR
/
K222424
View Source
Protect-It Custom Fit Dental Guard
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222424
510(k) Type
Traditional
Applicant
DOC Brands, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/2022
Days to Decision
57 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
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
K
24
0810
Anti Grinding Guard
K
23
2238
Goyo Mouthpiece S
K
23
1865
Mouth Guard (ATG0603R)
K
22
1369
FBCC Night Guard
K
22
2424
Protect-It Custom Fit Dental Guard
K
21
2706
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K
21
1158
NTI ClenchGuard
K
20
2974
DenTek Fresh Protect Dental Guard
K
19
3577
SleepRight ProRx Custom Dental Guard
K
18
1005
ClenchGuard
Show All 40 Submissions
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
/
OBR
/
K222424
View Source
Protect-It Custom Fit Dental Guard
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222424
510(k) Type
Traditional
Applicant
DOC Brands, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/2022
Days to Decision
57 days
Submission Type
Summary