Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K123613
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K123613
Device Name
Powder, Porcelain
Applicant
ARDENT INC
175 Pineview Dr
Amherst, NY 14228 US
Other 510(k) Applications for this Company
Contact
DONNA M HARTNETT
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
11/23/2012
Decision Date
02/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact