PMDA device listing

オブチュレーションガッターNT

PMDA Medical device listing · 221AFBZX00091000 · Class II

Key facts

PMDA document key 480179_221AFBZX00091000_A_01
Brand names オブチュレーションガッターNT
General names (JMDN) 歯科用根管充填固状材料
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 221AFBZX00091000
JMDN codes 70873000
Category code C0400
Marketing authorization holder 製造販売/株式会社東洋化学研究所
Package insert date Jun 1, 2021
Latest revision 2017-10
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:

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