Information Regarding the Use of Clear Aligner Orthodontic System（Invisalign）
In providing information to patients on our website, we disclose the following in accordance with the “Four Conditions for Disclosure of Unapproved Medical Devices.”

■ Statement of Unapproved Medical Device Status
The clear aligner orthodontic system “Invisalign” has not been approved under the Japanese Pharmaceuticals and Medical Devices Act (PMD Act).

■ Source and Procurement
“Invisalign” is a product of Align Technology, Inc. (USA). Our clinic officially obtains and utilizes the system through Align Technology Japan.

■ Availability of Approved Alternatives in Japan
In Japan, there are other clear aligner orthodontic devices that have been developed and marketed, and some of them have obtained regulatory approval.
To be recognized as an “orthodontic medical device” in Japan, the device must either:
•Be made from materials that are officially approved under the PMD Act and manufactured by a licensed Japanese dentist or dental technician, or
•Be a pre-manufactured device with PMD Act approval.
Since Invisalign is manufactured overseas, it does not fall under these categories and is therefore regarded as an unapproved medical device in Japan.

■ Safety Information in Other Countries
Invisalign has been used in over 18 million cases worldwide as a proven orthodontic treatment system. Excluding the general risks inherent in orthodontic treatment itself, there have been no reports of serious adverse effects specific to Invisalign®.

■ Important Notice
As Invisalign is not approved under the PMD Act in Japan, it is not covered under the Japanese “Relief System for Adverse Drug Reactions.”