Not Every TENS Unit is FDA Approved for DENTAL Use: What Type of TENS is being Used on You?

HomeAbout OC | OC Masterclass Training | Course Schedule | Registration | Accommodations | About Dr. Chan | Study Club | Doctor EducationPatient EducationVision | Research Group | Science | Orthodontics | LaboratoryDr. Chan’s ArticlesGNM Dentistry | Contact Us | Partners | Dr. Chan’s Blog Notes  |  Finding a GNM Dentist

Doctor Education
Patient Education

Did you know . . . The Myotronics J5 Dental TENS is the only TENS of any type that has been approved by FDA and Japan’s Health Ministry for Dental use and application in diagnosis and treatment of TMD.  Because of strict regulatory requirements of both the United States and Japan’s government for all its products, especially the J5 Dental TENS, the Japanese government has kept all medical TENS out of their dental market.  So, Myotronics J5 Dental TENS is the only TENS marketed for dental applications in Japan.

The questions to ask all dentists who are using TENS for dental application and use are:

  1. Is your TENS FDA approved for treatment of TMD? Yes or No
  2. Is your TENS FDA approved for muscle relaxation? Yes or No
  3. Is your TENS FDA approved for physiologic bite registration? Yes or No

Never assume all TENS units sold on the market whether sold on amazon or other places are FDA 510K approved specifically for DENTAL APPLICATION and USE. Not every TENs unit is FDA approved for dental application.  Don’t be fooled when some use the “FDA” terms.

Many TENS units are approved as a medical TENS devices. But not all have FDA approval for dental use nor are they all designed to function as a dental TENS device. Only Myotronics, Inc. 4 channel J5 Dental TENS is approved for its intended uses. For instance, certain units have a maximum current exceeding 100 mill amp which is dangerous for dental applications because they are designed to TENS larger muscles such as leg muscles. A dental device has a maximum current of 25 mA for safety reason. There is a huge difference what type of TENS is applied to your face and jaws.

The TENS unit that OC GNM dentists are trained to use is the J5 Myotronics 4 channel TENS unit that is the only 4 channel TENS unit that is FDA approved for:

  1.  Treatment of TMD
  2.  For muscle relaxation and
  3.  For physiologic bite registration.

I personally do not use medical TENS for my dental application because medical TENS is not approved or intended for such use. They are all rated differently by the FDA.  As a dentist I rather be safe than sorry.

What all TMD folks should be asking their dentists is:

  1. What type of TENS units are dentists using on you to treat you?
  2. Is there a particular TENS unit they are using that is not approved for dental application and use?
  3. Is your dentist using FDA approved TENS units that are approved for 1) treatment of TMD, 2) for muscle relaxation and 3) for physiologic bite registration.

These are the questions every consumer dental patient needs to ask.  Know and be aware of what kind of TENS is being used on you for these particular applications.

Clayton Dentistry


To Read More: PHYSIOLOGIC REST – A Key to Effective Diagnosis and Treatment

GNM footer

9061 West Post Road, Las Vegas, Nevada 89148 United States  Telephone: (702) 271-2950


Leader in Gneuromuscular and Neuromuscular Dentistry