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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Miscellaneous Devices
CFR Sub-Part
Physical Medicine Diagnostic Devices
CFR Sub-Part
KZM
Device, Muscle Monitoring
2
Product Code
K
16
1716
TEETHAN 2.0
2
Cleared 510(K)
K
13
0158
M-SCAN
2
Cleared 510(K)
K
11
3677
GRINDCARE MEASURE
2
Cleared 510(K)
K
08
2927
BIOEMG III
2
Cleared 510(K)
K
04
3373
DOLOTENS DENTAL TM 1
2
Cleared 510(K)
K
03
0869
BITESTRIP
2
Cleared 510(K)
K
00
3176
BIOEMG II AND BIOJVA
2
Cleared 510(K)
K
00
3287
MODEL K7 EVALUATION DEVICE
2
Cleared 510(K)
K
99
2694
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
2
Cleared 510(K)
K
98
1563
BIOPAK MEASUREMENT SYSTEM
2
Cleared 510(K)
Show All 19 Submissions
Physical Medicine Prosthetic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic 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
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Unknown
Review Panel
Last synced on 9 June 2023 at 11:04 pm
DE
/
physical-medicine-diagnostic-devices
/
KZM
/
K161716
View Source
TEETHAN 2.0
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161716
510(k) Type
Traditional
Applicant
BTS S.P.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/21/2016
Days to Decision
183 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Diagnostic Devices
General Hospital and Personal Use Miscellaneous Devices
Miscellaneous
Miscellaneous Devices
Physical Medicine Diagnostic Devices
KZM
Device, Muscle Monitoring
K
16
1716
TEETHAN 2.0
K
13
0158
M-SCAN
K
11
3677
GRINDCARE MEASURE
K
08
2927
BIOEMG III
K
04
3373
DOLOTENS DENTAL TM 1
K
03
0869
BITESTRIP
K
00
3176
BIOEMG II AND BIOJVA
K
00
3287
MODEL K7 EVALUATION DEVICE
K
99
2694
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K
98
1563
BIOPAK MEASUREMENT SYSTEM
Show All 19 Submissions
Physical Medicine Prosthetic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic 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
/
physical-medicine-diagnostic-devices
/
KZM
/
K161716
View Source
TEETHAN 2.0
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161716
510(k) Type
Traditional
Applicant
BTS S.P.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/21/2016
Days to Decision
183 days
Submission Type
Statement