Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Miscellaneous DevicesCFR Sub-Part
- Physical Medicine Diagnostic DevicesCFR Sub-Part
- KZMDevice, Muscle Monitoring2Product Code
- K161716TEETHAN 2.02Cleared 510(K)
- K130158M-SCAN2Cleared 510(K)
- K113677GRINDCARE MEASURE2Cleared 510(K)
- K082927BIOEMG III2Cleared 510(K)
- K043373DOLOTENS DENTAL TM 12Cleared 510(K)
- K030869BITESTRIP2Cleared 510(K)
- K003176BIOEMG II AND BIOJVA2Cleared 510(K)
- K003287MODEL K7 EVALUATION DEVICE2Cleared 510(K)
- K992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I2Cleared 510(K)
- K981563BIOPAK MEASUREMENT SYSTEM2Cleared 510(K)
- Show All 19 Submissions
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
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- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
TEETHAN 2.0
- Page Type
- Cleared 510(K)
- 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