Manufacturer registered with FDA
Pac-Dent Inc.
Brea, CA, United States. Lists 61 dental device types with FDA across 3 registered establishments, and holds 5 510(k) clearances as applicant.
- Device types listed
- 61
- Brands and models
- 70
- 510(k) clearances
- 52021–2022
- Markets registered in
- 12104 registrations outside the US
- Establishments
- 3China, United States
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Pac-Dent Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Pac-Dent Inc. | 5 clearances | 2021–2022 | Below |
| Canada | Health Canada | Registration holder | PAC-DENT INC.SUZHOU PAC-DENT TECHNOLOGY CO. LTD. | 54 | 2014–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Suzhou Pac-Dent Technology Co., Ltd.iBrite Suzhou Technology Co., Ltd | 21 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SUZHOU PAC-DENT TECHNOLOGY CO., LTD | 7 | — | Pure Global AI |
| China | NMPA | Registration holder | 派克顿公司PAC-DENT INC.派克顿公司Pac-Dent, Inc. | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Pac-Dent Inc.Suzhou Pac-Dent Technology · Suzhou Pac-Dent Technology Co., Ltd. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Suzhou Pac-Dent Technology Co., LtdPac Dent | 4 | 2007–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Suzhou Pac-Dent Technology Co Ltd | 3 | 2020–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PAC-DENT INC.SUZHOU PAC-DENT TECHNOLOGY CO., LTD. · Suzhou Pac-Dent Technology Co., Ltd | 3 | 2019–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Suzhou Pac-Dent Technology Co., Ltd. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PAC-DENT, INC. | 1 | 2026–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | iBrite Suzhou Technology Co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Pac-Dent Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | OptiCompRapidCeramRodin 3D Ceramic Nanohybrid ResinRodin Sculpture 2 | 2022 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2017 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | PJ-01 ProJect Composite Dispensing Gun | 2017 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | — | 2017 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | 131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk131120 EzAim ComforTab Adhesive Sensor Holder Posterior Yellow, 50/pk131120 EzAim Individually Cut Adhesive Sensor Holder Posterior Yellow, 50/pk | 2017 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | AntiSplatr Disposable Prophy Angles | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | — | 2017 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Dental CementEMA · Class 2 | Dental cements | Maker | PacTemp Automix NEPacTemp Automix NE Releasing AgentPacTemp Automix Releasing AgentRodin Envision veneer cementRodin Luting Cement | 2019 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | iMatrix Clear | 2017 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Pac-Dent Disposable Tray, Tooth Whitening | 2017 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | — | 2017 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Rodin TruModel | 2017 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Rodin 3D Resin Denture Base | 2022 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | — | 2017 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ACCLEAN ERGO PROPHY ANGLE LFAntiSplatr Disposable Prophy AnglesAntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ctAntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ctAntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ctAntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ctFreestyle ProProAngleProMateProMate EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler 2 moreProMate EZ-Q Quick Disconnect Hygiene HandpieceProMateEZ-Q Quick Disconnect Coupler | 2017 |
| X-Ray CollimatorEHB · Class 1 | — | Maker | — | 2017 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | — | 2017 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Pac-Dent Disposable Mouth Prop | 2017 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | — | 2017 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Promin Dental Desensitizing Gel341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml | 2017 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | JS Dental | 2017 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2017 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | EtchPro Etching GelPacBond One | 2022 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Rodin 3D Resin Clear Bite Spl | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Pac-Dent SG | 2018 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | — | 2018 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | — | 2018 |
| Pulp TesterEAT · Class 2 | — | Maker | PacEndo Vital Ice 360 Green 1 bottle 6ozPacEndo Vital Ice 360 Green 12 bottles per case | 2017 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2019 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | — | 2023 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2017 |
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | — | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | — | 2021 |
| Shellac Base PlateEEA · Class 1 | — | Maker | — | 2018 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Medidenta High Speed Handpieces | 2022 |
| Articulation PaperEFH · Class 1 | — | Lister | — | 2017 |
| Roll CottonEFN · Class 1 | — | Lister | — | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Rodin 3D Resin Try-In | 2022 |
| X-Ray Beam AlignerEHA · Class 1 | — | Lister | EzAim X-Ray Positioning System | 2022 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Endo Aid KitEndo organizer | 2024 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | — | 2017 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | — | 2017 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Lister | — | 2017 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | FINGER SPREADERG-FILE METALJS DentalLENTULO PSTE FILLSPIRAL PASTE FILL | 2022 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | JS Dental | 2017 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | JS Dental | 2019 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | FINGER PLUGGERJS Dental | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2017 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | — | 2017 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Rodin InteCem Intermediate Restorative Material | 2023 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | — | 2017 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | — | 2017 |
| Resin ApplicatorKXR · Class 1 | — | Lister | — | 2018 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Promin Dental Desensitizing Gel341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml | 2024 |
| Dental Stain EraserMAU · Class 1 | — | Maker | iBrite Teeth Whitening Gel | 2017 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Rodin IO | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Pac-Dent Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Dec 2022 | K202674 | Medidenta High Speed Handpieces | EFB Dental Air-Powered Handpiece |
| 25 May 2022 | K202920 | OptiComp | EBF Resin Tooth Shade Material |
| 28 Jul 2021 | K210189 | Pac-Dent Denture Base Resin | EBI Rebasing Repairing Relining Denture Resin |
| 26 Jul 2021 | K210412 | Pac-Dent Ceramic Nanohybrid Resin | EBF Resin Tooth Shade Material |
| 16 Jul 2021 | K210186 | PacBond One | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: The Belport Company, Inc. DBA Gingi-Pak (1).
Also lists devices cleared under other names
Pac-Dent Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Belport Company, Inc., Gingi-Pak (5), Pac-Dent International, Inc. (2), The Belport Company, Inc. DBA Gingi-Pak (1), Saeshin Precision Co., Ltd. (1), Scientific Pharmaceuticals (1), Pac-Dent International (Suzhou), Ltd. (1), Prime Dental Manufacturing, Inc. (1), Detax GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Aug 2026 | K261937 | PacTemp Automix NE | The Belport Company, Inc. DBA Gingi-Pak | EMA Dental Cement |
| 2 Sep 2025 | K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | EMA Dental Cement |
| 20 Jun 2024 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI Rebasing Repairing Relining Denture Resin |
| 13 Jun 2024 | K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | LBH Cavity Varnish |
| 27 Mar 2023 | K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | EBD Resin Filling Material Coating |
| 2 Sep 2020 | K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | KLE Resin Tooth Bonding Agent |
| 28 Jul 2015 | K151150 | Elements | Pac-Dent International, Inc. | ELW Impression Material |
| 29 Jun 2015 | K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 13 Aug 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Pac-Dent International, Inc. | EBF Resin Tooth Shade Material |
| 7 Sep 2005 | K051952 | EUGENONE | Scientific Pharmaceuticals | EMA Dental Cement |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 21 Jul 1987 | K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Crown Delta Corp. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| iBrite Suzhou Technology Co., LtdFDA reg. 3015491448 | SUZHOU CITY Jiangsu, China | Contract manufacturer, Contract sterilizer, Repacker / relabeler |
| PAC-DENT INC.FDA reg. 2086043 | Brea, CA, United States | Manufacturer, Repacker / relabeler, Specification developer |
| Suzhou Pac-Dent Technology Co., LtdFDA reg. 3004046477 | SUZHOU CITY Jiangsu, China | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Suzhou Pac-Dent Technology Co., Ltd. · iBrite Suzhou Technology Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056434). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.