Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
2025312443
Device Listing 2025312443
Listing Summary
#
Listing key
2025312443
Premarket submission
K160800
Device
DuoCem
Applicant
Coltene/Whaledent AG
Product code
EMA
Decision date
2016-11-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
25257
9613375
3002806620
COLTENE/WHALEDENT AG
1
N
2026-01-01
FELDWIESENSTRASSE 20 ALTSTAETTEN Sankt Gallen CH CH-9450