CARESTREAM DENTAL, LLC
FDA Regulatory Profile
CARESTREAM DENTAL, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1268-2021, Class II) was initiated on February 15, 2021. Its most recent 510(k) clearance was granted on September 12, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1268-2021 | Class II | Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to re | February 15, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K122427 | CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE | September 12, 2012 |