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Data / Medical devices / United States / Shofu Dental Corp.

Shofu Dental Corp.: FDA-registered device maker in San Marcos, CA, United States, 31 510(k) clearances

Shofu Dental Corp. is registered with the FDA (registration 2916735) in San Marcos, CA, United States. It lists 19 device types. The FDA files 31 510(k) clearances under its listings, the newest dated December 9, 2025. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Shofu Dental Corp.
FDA registration number
2916735
Address
1225 Stone Dr, San Marcos, CA, United States, 92078
Owner or operator
SHOFU INC. (9056340)
Roles
Repackager or relabeler
First device listed
June 5, 1978
Registered through
2027
Brand names listed
ACRYLIC KIT HP, ACRYLIC POLISHING KIT, ACRYLIC POLISHING KIT HP, ACRYPOINT, AMALGAM & ALLOY POLISHING KIT CA, AMALGAM & ALLOY POLISHING KIT FG, AMALGAM & METALS KIT CA, AMALGAM & METALS KIT FG and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Repackager or relabeleraccessdata.fda.gov
Coating, Filling Material, ResinEBD2Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Intraoral CameraQJK2Repackager or relabeleraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Mouthguard, PrescriptionMQCURepackager or relabeleraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeleraccessdata.fda.gov
Powder, PorcelainEIH2Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Repackager or relabeleraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Repackager or relabeleraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 9, 2025K252808GlasIonomer FX-LCEMASubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
October 28, 2025K252165ZIRCONOMER PEMASubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
July 11, 2025K251470ResiCem EXEMASubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
September 28, 2023K233161BeautiLink SAEMASubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
March 31, 2023K230003Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIHSubstantially EquivalentTopzir Biotech Co., Ltd.accessdata.fda.gov
September 22, 2022K222253GlasIonomer FX ULTRAEMASubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
March 18, 2022K213965BeautiBond XtremeKLESubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
March 18, 2022K212939Vintage Prime PressEIHSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
February 26, 2021K201387Ultrafast, Ultrafast Plus, Ultrafast LiteNVKSubstantially EquivalentDentlight, Inc.accessdata.fda.gov
November 7, 2019K192153Portux CAD/CAM DiscEBGSubstantially EquivalentNew Stetic, SAaccessdata.fda.gov
October 3, 2019K191794Vintage Art UniversalEIHSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
January 9, 2019K182869Fit SAEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
December 18, 2018K181496VINTAGE PROEIHSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
September 26, 2018K180803BeautiBond UniversalKLESubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
June 11, 2018K180649BeautiCem Veneer KitEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
December 6, 2017K172530BEAUTIFIL Flow Plus XEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
August 31, 2017K172106SHOFU MZ Primer PlusKLESubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
August 16, 2017K163568SHOFU RESIN GLAZEEBDSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
January 11, 2017K162261CERAMAGE UPEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
November 21, 2016K161891HC PrimerKLESubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
October 19, 2016K160203ADAMANT ZIRCONIA DISCEIHSubstantially EquivalentAdamant Co., Ltd.accessdata.fda.gov
July 27, 2016K160596BEAUTIFIL II LSEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
July 21, 2016K160086SHOFU Enamel ConditionerEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
March 2, 2016K151700BEAUTIFIL II GingivaEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
January 8, 2016K152392VINTAGE LDEIHSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
December 11, 2015K152451VINTAGE Art LFEIHSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
December 10, 2015K151699BEAUTIFIL II EnamelEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
June 2, 2015K143524Fiber Disks and Blocks (TRINIA)EBFSubstantially EquivalentBicon, LLCaccessdata.fda.gov
July 16, 2013K131504UNIVERSAL OPAQUEEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
December 11, 2008K082744BEAUTIBONDKLESubstantially EquivalentShofu Dental Corp.accessdata.fda.gov
April 17, 2002K020481PULPDENT POST CEMENTEMASubstantially EquivalentPulpdent Corporationaccessdata.fda.gov

Compare with other makers

Updated December 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.