FDA.reportPublic FDA data

Erika Martin

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053830853005383085Erika Martin1N2026-01-01450 Commerce Drive Quakertown PA US 18951

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
245491457463625K983267DIGORA FOR WINDOWS 2.0MUH1998-12-30
245491113120081K252086DTX Studio AssistMYN2025-11-17
245491652332438K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)OAS2024-09-12
245491034722229K231898DTX Studio Clinic (4.0)LLZ2023-12-08
245491386142170K230505Orthopantomograph™ OP 3D LXOAS2023-06-09
245491142427537K213562DTX Studio Clinic 3.0LLZ2022-03-25
245491496541727K203156DTX Studio ClinicLLZ2020-11-20
245491135059590K200810IPS CaseDesignerLLZ2020-10-08
245491744993311K181932DTX Studio designPNP2019-03-01
245491188954181K180947Orthopantomograph OP 3DOAS2018-06-07
245491137832168K172224DTX Studio diagnoseLLZ2018-01-11
245492068883119K170813ORTHOPANTOMOGRAPH OP 3DOAS2017-04-07
245491155559879K163423Orthopantomograph OP300OAS2017-08-31
245491615813220K163122NobelClinician, DTX Studio implantLLZ2017-01-31
245491685891781K162799CliniviewLLZ2017-04-25
245491899421345K161634IPS CaseDesignerLLZ2016-11-10
245491078444672K133544OP300OAS2014-03-26
245491675382642K133231DIGORA OPTIMEMUH2014-03-20
245492033405782K122018OP300OAS2012-12-10
245491221634522K093683ORTHOPANTOMOGRAPH OP300MUH2010-10-06
245492067044747K092591ORTHOPANTOMOGRAPH OP30MUH2009-11-20
245491218283058K081925SNAPSHOTMUH2008-09-02
245491020505509K063773VOLUMETRIC TOMOGRAPHYOAS2007-01-31
245491470367817K043612ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200DEHD2005-02-09
245491712101375K041050DIGORA OPTIME (OR DIGORA ONTIME)MUH2004-06-15
245491757987559K022630MODIFICATION TO FOCUSEHD2002-10-09
245491968496750K001729FOCUSEHD2000-07-13
245491080733616
245491827332464
245491311765119
245491442737174

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAS82024-09-12
LLZ82023-12-08
MUH62014-03-20
EHD32005-02-09
MYN12025-11-17
PNP12019-03-01