PMDA device listing

SFろう

PMDA Medical device listing · 16100BZZ00940000 · Class II

Key facts

PMDA document key 530250_16100BZZ00940000_A_01
Brand names SFろう
General names (JMDN) 歯科用金ろう
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 16100BZZ00940000
JMDN codes 70773000
Category code C0100
Marketing authorization holder 製造販売/日本歯研工業株式会社
Package insert date May 7, 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)