FDA Browser
by
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
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
K
95
2218
JT-3 ELECTROGNATHOGRAPH
1
Cleared 510(K)
K
84
3951
SIROGNATHOGRAPH
1
Cleared 510(K)
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 31 January 2025 at 11:05 pm
DE
/
subpart-b—diagnostic-devices
/
NFS
/
K952218
View Source
JT-3 ELECTROGNATHOGRAPH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952218
510(k) Type
Traditional
Applicant
BIO-RESEARCH ASSOCIATES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1995
Days to Decision
133 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
EAS
Gel, Electrode, For Pulp Tester
EAT
Tester, Pulp
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
K
95
2218
JT-3 ELECTROGNATHOGRAPH
K
84
3951
SIROGNATHOGRAPH
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
/
NFS
/
K952218
View Source
JT-3 ELECTROGNATHOGRAPH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952218
510(k) Type
Traditional
Applicant
BIO-RESEARCH ASSOCIATES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1995
Days to Decision
133 days
Submission Type
Statement