FDA.reportPublic FDA data

SHOFU DENTAL CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29167352916735SHOFU DENTAL CORP.1Y2026-01-011225 Stone Dr SAN MARCOS CA US 92078

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
E235DD16BLMN0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm BL MN+1(760) 736-3277customer-service@shofu.com
E235DD16C1ML0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm C1 ML+1(760) 736-3277customer-service@shofu.com
E235DD16C1MN0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm C1 MN+1(760) 736-3277customer-service@shofu.com
E235DD16C2ML0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm C2 ML+1(760) 736-3277customer-service@shofu.com
E235DD16C2MN0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm C2 MN+1(760) 736-3277customer-service@shofu.com
E235DD16D2ML0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm D2 ML+1(760) 736-3277customer-service@shofu.com
E235DD16D2MN0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm D2 MN+1(760) 736-3277customer-service@shofu.com
E235DD16D3MN0DENTADISC - DentaDisc PMMA CAD/CAM DISC. 98.5X16mm D3 MN+1(760) 736-3277customer-service@shofu.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
217281519518071K252808GlasIonomer FX-LCEMA2025-12-09
217281979662302K252165ZIRCONOMER PEMA2025-10-28
217281500589160K251470ResiCem EXEMA2025-07-11
217281925479514K233161BeautiLink SAEMA2023-09-28
217281843777856K222253GlasIonomer FX ULTRAEMA2022-09-22
217281757017190K213965BeautiBond XtremeKLE2022-03-18
217281236784499K212939Vintage Prime PressEIH2022-03-18
217281659961614K201387Ultrafast, Ultrafast Plus, Ultrafast LiteNVK2021-02-26
217281808495780K192153Portux CAD/CAM DiscEBG2019-11-07
217281120783943K191794Vintage Art UniversalEIH2019-10-03
217282048235595K182869Fit SAEBF2019-01-09
217281757651970K181496VINTAGE PROEIH2018-12-18
217281363004539K180803BeautiBond UniversalKLE2018-09-26
217282005492428K180649BeautiCem Veneer KitEBF2018-06-11
217281181845870K172530BEAUTIFIL Flow Plus XEBF2017-12-06
217281758674293K172106SHOFU MZ Primer PlusKLE2017-08-31
217281347710973K163568SHOFU RESIN GLAZEEBD2017-08-16
217281438590340K162261CERAMAGE UPEBF2017-01-11
217281661447760K161891HC PrimerKLE2016-11-21
217281041506605K160596BEAUTIFIL II LSEBF2016-07-27
217281872039070K160203ADAMANT ZIRCONIA DISCEIH2016-10-19
217281311773134K160086SHOFU Enamel ConditionerEBF2016-07-21
217281594080006K152451VINTAGE Art LFEIH2015-12-11
217281393470796K152392VINTAGE LDEIH2016-01-08
217281283091077K151700BEAUTIFIL II GingivaEBF2016-03-02
217281527150979K151699BEAUTIFIL II EnamelEBF2015-12-10
217281012867931K143524Fiber Disks and Blocks (TRINIA)EBF2015-06-02
217281009711211K131504UNIVERSAL OPAQUEEBF2013-07-16
217281730155440K082744BEAUTIBONDKLE2008-12-11
217281263949445K020481PULPDENT POST CEMENTEMA2002-04-17
217281173726960
217281454856553
217281548506037
217281623218183
217281710358420
217281855675542
217281861033662
217281877329733
217281966458371

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF102019-01-09
EMA62025-12-09
EIH62022-03-18
KLE52022-03-18
NVK12021-02-26
EBG12019-11-07
EBD12017-08-16

PMN#

93 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next