Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213343
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K213343
Device Name
Material, Tooth Shade, Resin
Applicant
Saremco Dental AG
Gewerbestrasse 4
Rebstein CH-9445 CH
Other 510(k) Applications for this Company
Contact
Franca Schmid
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
10/07/2021
Decision Date
01/21/2022
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