Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191548
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K191548
Device Name
Cement, Dental
Applicant
Kerr Corporation
1717 W. Collins Ave
Orange, CA 92867 US
Other 510(k) Applications for this Company
Contact
Ardrena Jackson
Other 510(k) Applications for this Contact
Regulation Number
872.3275
More FDA Info for this Regulation Number
Classification Product Code
EMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2019
Decision Date
10/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact