Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210186
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K210186
Device Name
Agent, Tooth Bonding, Resin
Applicant
Pac-Dent, Inc.
670 Endeavor Circle
Brea, CA 92821 US
Other 510(k) Applications for this Company
Contact
Tom Peng
Other 510(k) Applications for this Contact
Regulation Number
872.3200
More FDA Info for this Regulation Number
Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2021
Decision Date
07/16/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact