Tokyo, N/A, Japan
Dentech Corp. recalls
1 recall recorded since 2018, most recently on 21 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 April 2021
- Terminated
- 12 January 2023
- Reason
- Removing parts for safety reasons due to possible breakage.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia, UK, Singapore, South Korea, Georgia, Taiwan Lithuania, Greece,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1676-2021
- Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.