Registered with FDA
Jmu Dental, Inc.
Fullerton, CA, United States. Lists 87 dental device types with FDA across 1 registered establishment.
- Device types listed
- 87
- Brands and models
- 150
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Jmu Dental, 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 | Lister | Adhesive, Resin, Compositedental composite, resin, cementFlowable Composite RestorativeUniversal Composite RestorativeWhitening Gel | 2025 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | COXO Handpiece, X TITAN HandpieceDental Electric MotorDental Electric Motor / Dental Implantation System | 2022 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | D1D3D5D6D6 LEDD600D7D7 LEDEndo Ultrasonic ActivatorPT 3 31 morePT MASTER 3PT-N5 LEDPT5S6S6 LEDU6U6 LEDU600U600 LEDUDS-AUDS-EUDS-E LEDUDS-JUDS-KUDS-LUDS-MUDS-N1UDS-N2UDS-N3UDS-N6UDS-N6 LEDUDS-PUltrasonic Periodontal Treatment DeviceUltrasonic ScalerUltrasonic Scaler,Multiple ModelsV1V2V3V6V6 LED,D600 LED; | 2018 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | A-Silicone Bite Registration MaterialImpression MaterialJMU Dental Impression Materials | 2022 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Phosphoric Acid Etching Gel, 37%RESINUniversal Light Cure Dental Adhesive | 2025 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Dental Electric MotorDental Electric Motor / Dental Implantation System | 2022 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | LED Curing Light | 2018 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | COXO Handpiece, X TITAN HandpieceJMU Dental High-speed Turbine Handpiece | 2024 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Endo MotorHandpiece, direct drive, ac-powered | 2021 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Imaging Plate ScannerX-Ray Sensors | 2021 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Adhesive, Resin, Composite | 2025 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | JMU Forward Pull Headgear | 2026 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | SALIVA EJECTOR, EVACUATOR TIPS | 2019 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Gates Glidden Drills (Engine-Driven Reamers) | 2026 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | Jmu | 2018 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Jmu | 2018 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | — | 2018 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | JMU Dental Anesthetic Needle | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Dental hand instrument | 2025 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | INSTRUMENT, DIAMOND, DENTAL | 2021 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | MATERIAL, IMPRESSION TRAY, RESIN | 2019 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Lister | JMU Dental LED Light | 2025 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | EVACUATOR, ORAL CAVITY | 2019 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Lister | C-AS1 | 2020 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | DISPOSABLE DENTAL SYRINGE, AIR/WATER SYRINGE TIPS | 2019 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | JMU Intra Oral Latex ElasticsJMU Intra Oral Latex Free ElasticsJMU JMU Intra Oral Elastics NeonJMU Ligature O-TiesJMU Mini Ligature O-TiesJMU Power Chain ContinuousJMU Power Chain LongJMU Power Chain ShortOrthodontic Elastics Placer | 2020 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | 1st Molar Rough Band w/ MBT Tube1st Molar Rough Band w/ Roth Tube | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | JMU Lingual Retainer Wires | 2026 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | Jmu | 2018 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | cheek retractor | 2022 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | JMU Aligner Chewie | 2026 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | Dental Dam | 2025 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | LED Whitening Light, LED Curing Light | 2019 |
| Articulation PaperEFH · Class 1 | — | Lister | Articulating Papers | 2026 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | JMU Needle Holder 14 cm/5 ½ | 2020 |
| Roll CottonEFN · Class 1 | — | Lister | COTTON ROLL | 2019 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | TOOTHBRUSH | 2019 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Orthodontic Wax | 2022 |
| ParallelometerEGI · Class 1 | Dental hand instruments | Lister | Dental Surveyor / Parallelometer | 2026 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Scissors, Surgical Tissue, Dental | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | JMU Dental X-Ray Positioning Aiming Ring | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups | 2019 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Micro blaster Standard (Midwest) | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | EHM - STRIP, POLISHING AGENT | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | DENTAL IMPRESSION TRAY, BITE REGISTRATION TRAY, DISPOSABLE IMPRESSION TRAY | 2019 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | TRAY, SURGICAL, INSTRUMENT | 2019 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | Curved Syringe with Graduation, 12 cc | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Pre Bent Needle Tips, Mixing Tips, Irrigation Syringe, Dental Needle | 2021 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | DYNAMIC HP MIXING TIPS; BENT NEEDLE TIPS; CURVED UTILITY SYRINGE; DISPENSING TIPS; IMPRESSION GUN; INTRA-ORAL TIPS | 2019 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | JMU Natural Latex Dental Rubber Dam | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Dental Retractor | 2021 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | C-type cheek retractor | 2026 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Dental Blocks CAD/CAM Glass Ceramic | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | baby tooth box; box; plastic dappen | 2019 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | HANDLE, INSTRUMENT, DENTAL | 2020 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Jmu | 2018 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Lister | Dental Aspirating Syringe | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | BUR, DENTAL | 2021 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Articulator | 2024 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Lister | DISPOSABLE TRAPS (FILTER); PLASTIC RETAINER/ DENTURE; CUSPIDOR STRAINER; AMALGAM CARRIER | 2019 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | Gutta Percha Pluggers | 2025 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta Percha Obturator | 2022 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | JMU Absorbent Paper Points | 2024 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Obturation System | 2022 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Spring Endo File | 2020 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | Synthetic Polymer Teeth | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Lister | dental composite, resin, cement | 2025 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2020 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | JMU Surgical Rongeur Forcep | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | JMU Surgical Elevator | 2020 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | JMU Ultrasonic Scaler Tip | 2026 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | JMU Sectional Matrix Bands | 2025 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Lister | Retainer Box, Denture Box | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | DENTAL FLOSS | 2019 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Lister | Mixing Tip | 2022 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | PLIER, ORTHODONTIC | 2020 |
| Tube Impression and MatrixKCQ · Class 1 | — | Lister | JMU Sectional Matrix Bands | 2024 |
| FacebowKCR · Class 1 | Articulators & facebows | Lister | Facebow | 2023 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | DENTAL BIB/ APRON | 2019 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | Dental Electric Motor / Dental Implantation System | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | SHEETS FOR TRAYS | 2021 |
| Resin ApplicatorKXR · Class 1 | — | Lister | MICRO APPLICATOR; VALUSTICK STICKY APPLICATOR; BENDABLE BRUSH APPLICATOR; COMPOSITE BRUSH AND REPLACEABLE TIP | 2019 |
| Tongue ScraperLCN · Class 1 | — | Lister | Tongue Cleaner | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Dental PRF Box & GRF Instruments Complete Set | 2021 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | Intraoral Scanner | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | AIR COMPRESSOR AND VACUUM UNIT; BARRIER FILM; HANDPIECE SLEEVES; INSTRUMENT TRAY SLEEVES; LIGHT/SENSOR SLEEVES/ POUCHES;BARRIER SLEEVES; SURRINGE SLEEVES; DENTAL TRAY COVER, HEADREST COVER, INTRAORAL CAMERA SHEATH | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | DENTAL CHAIR | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Jmu Dental, 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: Guilin Woodpecker Medical Instrument Co., Ltd. (6), Foshan COXO Medical Instrument Co., Ltd. (5), Rizhao HuGe Biomaterials Company, Ltd. (4), Dentscare Ltda (4), Liaoning Rachcera Material Technology Co.,Ltd. (1), Iray Technology Taicang , Ltd. (1), Shandong Huge Dental Material Corporation (1), Guangdong JINME Medical Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Dec 2024 | K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co.,Ltd. | EIH Porcelain Powder |
| 22 Sep 2023 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan COXO Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 18 May 2023 | K220829 | Endo Motor | Foshan COXO Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 23 Mar 2023 | K222096 | Endo Ultrasonic Activator | Foshan COXO Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 8 Dec 2022 | K220826 | LED Curing Light | Foshan COXO Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 12 Oct 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF Resin Tooth Shade Material |
| 27 Sep 2022 | K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan COXO Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 12 Sep 2022 | K221450 | Phosphoric Acid Etching Gel | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 14 Oct 2021 | K210231 | Vittra APS Unique | Dentscare Ltda | EBF Resin Tooth Shade Material |
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
| 6 Oct 2021 | K202063 | TrusFIL Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF Resin Tooth Shade Material |
| 27 Sep 2021 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 25 Sep 2020 | K201787 | Light Cure Dental Adhesive | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 24 Sep 2020 | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW Impression Material |
| 14 Aug 2020 | K192682 | Orthocem, Ortho Bite | Dentscare Ltda | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 13 Dec 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | KLE Resin Tooth Bonding Agent |
| 2 Nov 2019 | K183465 | Allcem, Allcem Core | Dentscare Ltda | EMA Dental Cement |
| 8 Nov 2017 | K170229 | Dental High-speed Turbine Handpiece | Guangdong JINME Medical Technology Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 8 Mar 2016 | K152766 | CharmFlex | Dentkist, Inc. | ELW Impression Material |
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | ELW Impression Material |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | DZI Powered Bone Drill |
| 16 Aug 2010 | K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | ELM Teeth Plastic Denture |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 16 Mar 1993 | K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | DZP Dental Diamond Instrument |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JMU DENTAL, INCFDA reg. 3014683120 | Fullerton, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058141). 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.