Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K173643
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K173643
Device Name
Material, Tooth Shade, Resin
Applicant
Bioloren S.R.L.
via Alessandro Volta 59
Saronno 21047 IT
Other 510(k) Applications for this Company
Contact
Ratti Umberto
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/27/2017
Decision Date
02/24/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact