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
1803367044
Device Listing 1803367044
Listing Summary
#
Listing key
1803367044
Premarket submission
K132109
Device
ENAMELAST
Applicant
Ultradent Products Inc. / Oratech, LLC
Product code
LBH
Decision date
2013-11-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
117927
3005174370
3005174370
3M ESPE DENTAL PRODUCTS
1
Y
2026-01-01
2510 Conway Ave. Saint Paul MN US 55144
330561
3031841433
3031841433
Solventum US LLC
1
N
2026-01-01
12930 IH 10 West San Antonio TX US 78249
348040
3042272797
3042272797
SOLVENTUM US LLC
1
N
2026-01-01
1750 Yankee Doodle Rd Eagan MN US 55121