International safety notice

Common name: (1) Chairside dental computer-aided design and manufacturing unit (2)-(6) Computer-aided design and manufacturing unit installed in dental laboratory Sales name: (1) CEREC Prime Scan AC (2) CEREC Prime Mill (3) In-Lab MC X5 (4) CEREC MC (5) inEOS X5 scanner (6) In-Lab MC XL

Japan / PMDA Recalls · JPN · Dec 2, 2022

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: (1) Chairside dental computer-aided design and manufacturing unit (2)-(6) Computer-aided design and manufacturing unit installed in dental laboratory Sales name: (1) CEREC Prime Scan AC (2) CEREC Prime Mill (3) In-Lab MC X5 (4) CEREC MC (5) inEOS X5 scanner (6) In-Lab MC XL
Manufacturer Dentsply Sirona Co., Ltd.
Models 111326, 111415, 111432, 111319, 603321, 111315, 111279, 603316, 406214, 111406, 603487, 111408 and 169 more
Date Dec 2, 2022
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices