FDA-Device2021-03-24Class II
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.
CARESTREAM DENTAL, LLC
Hazard
The mirror may become detached and fall from the unit
Sold states
Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.
Affected count
11400 devices
Manufactured in
3625 Cumberland Blvd Se Ste 700, N/A, Atlanta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief