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FDA 510(k) Application Details - K211813
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K211813
Device Name
Cleanser, Root Canal
Applicant
Inter-Med / Vista Dental
2200 South Street
Racine, WI 53404 US
Other 510(k) Applications for this Company
Contact
Brett Arand
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/11/2021
Decision Date
08/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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