PMDA device listing

スミプロイPCプラスター

PMDA Medical device listing · 24B3X00001000006 · Class I

Key facts

PMDA document key 850103_24B3X00001000006_A_01
Brand names スミプロイPCプラスター
General names (JMDN) 歯科用焼石こう
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 24B3X00001000006
JMDN codes 70897010
Category code C0800
Marketing authorization holder 製造販売/株式会社 菱化デンタル
Package insert date Jun 29, 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)