PMDA device listing

KP ラバーダム

PMDA Medical device listing · 13B1X10394310001 · Class I

Key facts

PMDA document key 790122_13B1X10394310001_A_01
Brand names KP ラバーダム
General names (JMDN) 歯科用ラバーダム
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X10394310001
JMDN codes 11155010
Category code A6700
Marketing authorization holder 製造販売/株式会社モリムラ
Package insert date Jun 1, 2026
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)