PMDA device listing

ワックスディスク Smile

PMDA Medical device listing · 36B2X10006000142 · Class I

Key facts

PMDA document key 800171_36B2X10006000142_F_01
Brand names ワックスディスク Smile
General names (JMDN) 歯科用キャスティングワックス
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 36B2X10006000142
JMDN codes 16189000
Category code C0700
Marketing authorization holder 製造販売/株式会社クエスト
Package insert date Jun 30, 2021
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)