Skip to the page
Get started – free

Data / Medical devices / United States / Pac-Dent Inc.

Pac-Dent Inc.: FDA-registered device maker in Brea, CA, United States, 26 510(k) clearances

Pac-Dent Inc. is registered with the FDA (registration 2086043) in Brea, CA, United States. It lists 84 device types. The FDA files 26 510(k) clearances under its listings, the newest dated August 7, 2026. Registered through 2027. FDA data exported November 2, 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 Pac-Dent Inc.
FDA registration number
2086043
FEI number
3000719964
Address
670 Endeavor Cir, Brea, CA, United States, 92821
Owner or operator
Pac-Dent Inc. (10056434)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 8, 2017
Registered through
2027
Brand names listed
131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk, 131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk, 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk, 131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk, 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk, 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk, 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Repackager or relabeler, Specification developeraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Aligner, Beam, X-RayEHA1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cleanser, Root CanalKJJUSpecification developeraccessdata.fda.gov
Coating, Filling Material, ResinEBD2Manufactureraccessdata.fda.gov
Collimator, X-RayEHB1Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Device, Heat-SealingKSD1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Repackager or relabeleraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Repackager or relabeleraccessdata.fda.gov
Eraser, Dental StainMAU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Finger CotLZB1Repackager or relabeleraccessdata.fda.gov
Frame, Rubber DamEJE1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Specification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Repackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Repackager or relabeleraccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufactureraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Paper, ArticulationEFH1Repackager or relabeleraccessdata.fda.gov
Pick, MassagingJET1Repackager or relabeleraccessdata.fda.gov
Plate, Base, ShellacEEA1Repackager or relabeler, Specification developeraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Specification developeraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufactureraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeleraccessdata.fda.gov
Reliner, Denture, Over The CounterEBP2Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.fda.gov
Retainer, MatrixJEP1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tester, PulpEAT2Manufactureraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Repackager or relabeleraccessdata.fda.gov
Zinc Oxide EugenolEMB1Manufactureraccessdata.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
August 7, 2026K261937PacTemp Automix NEEMASubstantially EquivalentThe Belport Company Inc., DBA Gingi-Pakaccessdata.fda.gov
September 2, 2025K251775RODIN CementEMASubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
June 20, 2024K240688RODIN Titan 3D ResinEBISubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
June 13, 2024K231060ProMin Dental Desensitizing GelLBHSubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
March 26, 2024K231793RODIN 3D Resin SPLINT, Hard/FlexMQCSubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
March 27, 2023K223365RODIN Palette Naturalizing KitEBDSubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
December 12, 2022K202674Medidenta High Speed HandpiecesEFBSubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
May 25, 2022K202920OptiCompEBFSubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
July 28, 2021K210189Pac-Dent Denture Base ResinEBISubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
July 26, 2021K210412Pac-Dent Ceramic Nanohybrid ResinEBFSubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
July 16, 2021K210186PacBond OneKLESubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
September 2, 2020K200462EtchPro Etching GelKLESubstantially EquivalentBelport Company, Inc., Gingi-Pakaccessdata.fda.gov
July 25, 2016K160577PacEndo ChlorhexidineKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
June 7, 2016K160232Disposable Barrier Sleeves and CoversPEMSubstantially EquivalentDentsply International, Inc.accessdata.fda.gov
March 3, 2016K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEMSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
February 1, 2016K153528PacEndo EDTAKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
November 10, 2015K151852PacEndo Sodium HyprochloriteKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
July 28, 2015K151150ElementsELWSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
June 29, 2015K143411TRAUS ENDOEKXSubstantially EquivalentSaeshin Precision Co., Ltd.accessdata.fda.gov
August 13, 2013K130672OPTIFLOW II FLOWABLE COMPOSITE, LCEBFSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
September 7, 2012K113761INFRARED THERMOMETERFLLSubstantially EquivalentFamidoc Technology Co., Ltd.accessdata.fda.gov
September 7, 2005K051952EUGENONEEMASubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
April 14, 2003K030603PROANGLE DISPOSABLE PROPHY ANGLEEGSSubstantially EquivalentPac-Dent International (Suzhou), Ltd.accessdata.fda.gov
November 1, 2001K012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTEBCSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
February 16, 2000K994012TEMPOFIT, MODEL 02693EBGSubstantially EquivalentDetax GmbH & Co. KGaccessdata.fda.gov
July 21, 1987K872745VINYL POLYSILOXANE IMPRESSION SYSTEMELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. 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.