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
1295506827
Device Listing 1295506827
Listing Summary
#
Listing key
1295506827
Premarket submission
K180477
Device
Straumann PURE Ceramic Implant System
Applicant
Institut Straumann AG
Product code
DZE
Decision date
2019-01-04
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
13338
1222315
1000121052
Straumann USA, LLC
1
Y
2026-01-01
60 MINUTEMAN RD. ANDOVER MA US 01810
45326
9613348
3004975279
INSTITUT STRAUMANN AG
1
N
2026-01-01
PETER MERIAN-WEG 12 BASEL Basel-Stadt CH CH-4002
45327
9614404
3002807318
Straumann Villeret SA
1
N
2026-01-01
LES CHAMPS DU CLOS 2 VILLERET Bern CH CH-2613
210595
3033781108
3033781108
Straumann Manufacturing, Inc.
1
N
2026-01-01
60 Minuteman Road Andover MA US 01810