FDA.reportPublic FDA data

Promethean Restorative Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304005393030400539Promethean Restorative Inc.1N2026-01-01333 Perry St Ste 210 Castle Rock CO US 80104

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3267191395237529K252962DYNAMIS™ Navigation SystemOLO2026-01-12
3267191621146274K251075DYNAMIS™ Implant SystemOUR2025-04-25
3267191971328764K243565DYNAMIS™ SI Screw SystemOUR2025-02-28
3267191707808136

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR22025-04-25
OLO12026-01-12