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
2063400506
Device Listing 2063400506
Listing Summary
#
Listing key
2063400506
Premarket submission
K151123
Device
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Applicant
Pac-Dent International, Inc.
Product code
PEM
Decision date
2016-03-03
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
3611
1718912
1718912
Ultradent Products Inc.
1
Y
2026-01-01
505 W Ultradent Dr (10200 South) South Jordan UT US 84095