FDA.reportPublic FDA data

3SHAPE TRIOS A/S

Matched from indexed company URL: 3shape Trios A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
300956001330095600133SHAPE TRIOS A/S1N2026-01-01Holmens Kanal 7 copenhagen Hovedstaden DK 1060

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05902729753722TRIOS 5 - The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.+4570272620support@3shape.com
05902729753906TRIOS Ready Tip - TST-15+4570272620support@3shape.com
05902729753982TRIOS 6 - L1P-2+4570272620support@3shape.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1397831185670927K260082TRIOS Dx (R1)SHQ2026-04-10
1397831669311480K242103TRIOS Ready TipNBL2025-04-04
1397831567106466K221249L1P-1F (TRIOS 5)NBL2022-09-16
1397831278257567
1397831809842843
1397831281181960

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBL22025-04-04
SHQ12026-04-10

PMN#

GUDID#

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