Recall Z-1676-2021— Dentech Corp.
Class II · Terminated
Class II FDA medical device recall by Dentech Corp., initiated 2021-04-21, terminated 2023-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.. Reason: Removing parts for safety reasons due to possible breakage..
- Recalling firm
- Dentech Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-21
- Terminated
- 2023-01-12
- Firm location
- Tokyo, N/A, Japan
Product description
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Reason for recall
Removing parts for safety reasons due to possible breakage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.