FDA.reportPublic FDA data

Formlabs Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30102797883010279788Formlabs Inc.1Y2026-01-0135 Medford St Somerville MA US 02143
30154914413015491441Formlabs Ohio, Inc.1N2026-01-0127800 Lemoyne Rd Millbury OH US 43447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2282681541034711K240538Premium Teeth ResinEBG2024-07-19
2344731541034711K240538Premium Teeth ResinEBG2024-07-19
2282681466957739K232087Dental LT Comfort ResinMQC2024-02-16
2344731466957739K232087Dental LT Comfort ResinMQC2024-02-16
2282681176704043K222061Dental LT Clear V2 ResinMQC2022-11-10
2344731176704043K222061Dental LT Clear V2 ResinMQC2022-11-10
2282681553581136
2344731553581136
2282681623254256
2344731623254256
2282681724246908
2344731724246908

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQC42024-02-16
EBG22024-07-19

PMN#

GUDID#