PMDA device listing

ASIGA デンタトライ

PMDA Medical device listing · 12B1X10014000095 · Class I

Key facts

PMDA document key 670990_12B1X10014000095_A_01
Brand names ASIGA デンタトライ
General names (JMDN) 歯科咬合採得用材料
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 12B1X10014000095
JMDN codes 70883000, 70832000
Category code C0300
Marketing authorization holder 製造販売/株式会社フォレスト・ワン
Package insert date Jul 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:

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