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Straumann USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12223151000121052Straumann USA, LLC1Y2026-01-0160 MINUTEMAN RD. ANDOVER MA US 01810

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
133381877926785K243478Straumann InLab Validated WorkflowNHA2025-02-19
133381131810599K243278Custom AbutmentsNHA2025-02-21
133381242175777K192029Straumann PUREloc abutmentsNHA2019-10-28
133381656945777K191256Straumann BLX Ø3.5 mm ImplantsDZE2019-12-27
133381117811623K190654Straumann CI RD Ceramic Healing CapsNHA2019-06-28
133381109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
133381517343645K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZE2018-12-28
133381886638902K180791Straumann BLX Surgical CassetteKCT2018-06-21
133381295506827K180477Straumann PURE Ceramic Implant SystemDZE2019-01-04
133381906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
133381972094243K173961Straumann BLX Implant SystemDZE2018-06-05
133381760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
133381279490079K171649Straumann CARES M-Series CAD/CAM SystemNHA2018-02-22
133381259376659K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHA2014-08-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA92025-02-21
DZE42019-12-27
KCT12018-06-21

PMN#

71 records. Showing 1-40. Next