Recall Z-1268-2021— CARESTREAM DENTAL, LLC
Class II · Terminated
Class II FDA medical device recall by CARESTREAM DENTAL, LLC, initiated 2021-02-15, terminated 2023-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.. Reason: The mirror may become detached and fall from the unit.
- Recalling firm
- CARESTREAM DENTAL, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-15
- Terminated
- 2023-01-14
- Firm location
- Atlanta, GA, United States
Product description
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
Reason for recall
The mirror may become detached and fall from the unit
Data sourced from openFDA. This site is unofficial and independent of the FDA.