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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAS
Gel, Electrode, For Pulp Tester
1
Product Code
EAT
Tester, Pulp
2
Product Code
K
02
2097
THERMIQUE
2
Cleared 510(K)
K
02
1298
ELEMENTS DIAGNOSTIC UNIT
2
Cleared 510(K)
K
01
2427
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
2
Cleared 510(K)
K
01
1666
CHILLIT
2
Cleared 510(K)
K
99
0225
ENDO ANALYZER, MODEL 8005, MODIFIED
2
Cleared 510(K)
K
97
3439
ENDO ANALYZER, MODEL 8005
2
Cleared 510(K)
K
97
0715
SYSTEM B HEAT SOURCE
2
Cleared 510(K)
K
96
3862
TOUCH N' HEAT
2
Cleared 510(K)
K
96
0799
ORTHO-ICE
2
Cleared 510(K)
K
95
0237
DIGITEST
2
Cleared 510(K)
K
95
0238
GENTAL PULSE
2
Cleared 510(K)
K
94
0260
THERMAL PULP TESTER
2
Cleared 510(K)
K
93
0764
ENDO-ICE-PULP TESTER-THERMAL
2
Cleared 510(K)
K
88
3804
E-MITT (CONDUCTIVE HAND COVER)
2
Cleared 510(K)
K
88
1826
ENDO-ICE
2
Cleared 510(K)
K
87
2039
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
2
Cleared 510(K)
K
87
3644
PULP PEN
2
Cleared 510(K)
K
87
0118
MODEL 6110B DENTAPHOR
2
Cleared 510(K)
K
83
0105
VITATHYL
2
Cleared 510(K)
K
82
0598
HOT & COLD PULP TESTER #4001
2
Cleared 510(K)
K
80
0138
TS-301 THREE-WAY PULP TESTER
2
Cleared 510(K)
K
79
0799
PULPTESTER MODEL 2001
2
Cleared 510(K)
EGZ
Holder, Film, X-Ray
1
Product Code
EHA
Aligner, Beam, X-Ray
1
Product Code
JEO
Measurer, Gingival Fluid
1
Product Code
LFC
Device, Caries Detection
2
Product Code
MVH
Device, Detection, Sulfide
2
Product Code
NBL
Laser, Fluorescence Caries Detection
2
Product Code
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
1
Product Code
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
1
Product Code
NTK
Caries Detector, Laser Light, Transmission
2
Product Code
NYH
Plaque Disclosing Kit
2
Product Code
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 25 January 2026 at 3:41 am
DE
/
subpart-b—diagnostic-devices
/
EAT
/
K820598
View Source
HOT & COLD PULP TESTER #4001
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K820598
510(k) Type
Traditional
Applicant
ANALYTIC TECHNOLOGY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/1982
Days to Decision
15 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
EAS
Gel, Electrode, For Pulp Tester
EAT
Tester, Pulp
K
02
2097
THERMIQUE
K
02
1298
ELEMENTS DIAGNOSTIC UNIT
K
01
2427
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K
01
1666
CHILLIT
K
99
0225
ENDO ANALYZER, MODEL 8005, MODIFIED
K
97
3439
ENDO ANALYZER, MODEL 8005
K
97
0715
SYSTEM B HEAT SOURCE
K
96
3862
TOUCH N' HEAT
K
96
0799
ORTHO-ICE
K
95
0237
DIGITEST
K
95
0238
GENTAL PULSE
K
94
0260
THERMAL PULP TESTER
K
93
0764
ENDO-ICE-PULP TESTER-THERMAL
K
88
3804
E-MITT (CONDUCTIVE HAND COVER)
K
88
1826
ENDO-ICE
K
87
2039
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
K
87
3644
PULP PEN
K
87
0118
MODEL 6110B DENTAPHOR
K
83
0105
VITATHYL
K
82
0598
HOT & COLD PULP TESTER #4001
K
80
0138
TS-301 THREE-WAY PULP TESTER
K
79
0799
PULPTESTER MODEL 2001
EGZ
Holder, Film, X-Ray
EHA
Aligner, Beam, X-Ray
JEO
Measurer, Gingival Fluid
LFC
Device, Caries Detection
MVH
Device, Detection, Sulfide
NBL
Laser, Fluorescence Caries Detection
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
NTK
Caries Detector, Laser Light, Transmission
NYH
Plaque Disclosing Kit
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
/
subpart-b—diagnostic-devices
/
EAT
/
K820598
View Source
HOT & COLD PULP TESTER #4001
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K820598
510(k) Type
Traditional
Applicant
ANALYTIC TECHNOLOGY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/1982
Days to Decision
15 days