Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K222961
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K222961
Device Name
Powder, Porcelain
Applicant
Harvest Dental Products, LLC
905 Columbia Street
Brea, CA 92821 US
Other 510(k) Applications for this Company
Contact
Colleen Boswell
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2022
Decision Date
06/02/2023
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