PMDA device listing

CodentApolloタービンハンドピース

PMDA Medical device listing · 228AGBZX00085000 · Class II

Key facts

PMDA document key 470775_228AGBZX00085000_1_01
Brand names CodentApolloタービンハンドピース
General names (JMDN) 歯科用ガス圧式ハンドピース
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 228AGBZX00085000
JMDN codes 40958000
Category code A6100
Marketing authorization holder 製造販売/有限会社デンタルテクニカ
Package insert date Aug 2, 2022
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
  • Yes 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)