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Review Panel
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Review Panel
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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
K
19
3570
Dental Pain Eraser
U
Cleared 510(K)
K
19
2429
Dental Pain Eraser
U
Cleared 510(K)
K
18
2947
Dental Pain Eraser
U
Cleared 510(K)
K
01
1001
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
U
Cleared 510(K)
K
93
5304
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
U
Cleared 510(K)
K
93
5085
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
U
Cleared 510(K)
K
93
5082
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
U
Cleared 510(K)
K
91
5717
CEDETA
U
Cleared 510(K)
K
92
0119
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
U
Cleared 510(K)
K
91
0625
ULTRACALM
U
Cleared 510(K)
Show All 15 Submissions
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
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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Review Panel
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Review Panel
Orthopedic
Review Panel
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Review Panel
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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
/
LWM
/
K182947
View Source
Dental Pain Eraser
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182947
510(k) Type
Traditional
Applicant
Synapse Dental, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2019
Days to Decision
154 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
K
19
3570
Dental Pain Eraser
K
19
2429
Dental Pain Eraser
K
18
2947
Dental Pain Eraser
K
01
1001
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K
93
5304
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
K
93
5085
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
K
93
5082
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
K
91
5717
CEDETA
K
92
0119
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
K
91
0625
ULTRACALM
Show All 15 Submissions
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
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
/
LWM
/
K182947
View Source
Dental Pain Eraser
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182947
510(k) Type
Traditional
Applicant
Synapse Dental, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2019
Days to Decision
154 days
Submission Type
Summary