Manufacturer registered with FDA
Hu-Friedy Mfg Co., LLC
Northbrook, IL, United States. Lists 53 dental device types with FDA across 4 registered establishments, and holds 8 510(k) clearances as applicant.
- Device types listed
- 53
- Brands and models
- 101
- 510(k) clearances
- 81991–2012
- Markets registered in
- 104,456 registrations outside the US
- Establishments
- 4China, Germany, United States
510(k) clearances per year, 1990–2026
Registered in 10 markets
Where regulators' registries name Hu-Friedy Mfg Co., LLC 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 | Hu-Friedy Mfg Co., LLC | 8 clearances | 1991–2012 | Below |
| Thailand | Thai FDA | Manufacturer | HU-FRIEDY MFG. CO., LLC.HU-FRIEDY MFG. CO.,LLC · HU-FRIEDY MFG. CO., INC. | 3,892 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hu-Friedy Mfg. Co,. LLCHU-FRIEDY MFG. CO., INC. · Hu-Friedy Mfg. Co., Inc. · +2 | 142 | 1998–2019 | Pure Global AI |
| Colombia | INVIMA | Registration holder | HU-FRIEDY MFG. CO. LLCHU-FRIEDY MFG, CO., LLC · HU-FRIEDY MFG. CO. LLC ZWEIGNIEDERLASSUNG DEUTSC · +1 | 135 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Hu-Friedy Mfg. Co., LLCHu-Friedy Mfg. Co. LLC | 134 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hu Friedy Mfg Co IncHu Friedy Mfg Co LLC | 63 | 2004–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HU-FRIEDY MFG. CO., LLCHU FRIEDY MFG CO., INC · HU-FRIEDY MFG CO., INC · +1 | 52 | 2005–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HU-FRIEDY MFG CO., LLC | 18 | 2007–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HU-FRIEDY MFG. CO.LLCHU-FRIEDY MFG. CO. LLC | 15 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Hu-Friedy MFG Co. LLC.Hu Friedy MFG Co. LLC | 5 | — | 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 Hu-Friedy Mfg Co., LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | After FiveAfter Five PlusFurcation PlusHu-Friedy Mfg Co.,LLCHuFriedyGroupProphy PlusProphy StylePWR AirPWR HandpiecePWR Pair 9 morePWR PiezoPWR Piezo TipsStreamlineSubgingival PWR Perio TipsSwerv3 Ultrasonic ScalerSwivelSwivel Direct FlowSymmetry IQ Ultrasonic GeneratorSymmetry Piezoelectric Scaling Tips | 2007 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co., LLC | 1998 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | DENTAL ELEVATORSHu-Friedy Mfg Co.,LLCROOT TIP ELEVATORS | 1977 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co., LLC | 1998 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCORTHODONTIC BAND PUSHER | 1977 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Endo PlierHu-Friedy Mfg Co.,LLC | 1998 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCMARGIN FINISHING | 1977 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCMARGIN FILEMULIPLE | 1977 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | DENTAL EXPLORERHu-Friedy Mfg Co.,LLC | 1977 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | AMALGAM AND FOILAMALGAM PLUGGERSHu-Friedy Mfg Co.,LLC | 1977 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCPULP CANAL FILLING MATERIAL | 1977 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPSHu-Friedy Mfg Co., LLC | 1998 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCRongeurs | 1998 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co., LLC | 1977 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCKnife | 1998 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Maker | Periodonitic Marker | 1998 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Hu-Friedy Mfg Co.,LLCPumice Cup | 1998 |
| Preformed BarEHO · Class 1 | — | Lister | Hu-Friedy Mfg Co | 2014 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Hu-Friedy Mfg Co.,LLC | 2011 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co., LLC | 2009 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | Hu-Friedy Mfg Co.,LLCRubber Dam Frame | 1998 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Cartridge SyringeHu-Friedy Mfg Co.,LLC | 2013 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Hu-Friedy Mfg Co.,LLC | 2003 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | AMALGAM CARVERSFILESHu-Friedy Mfg Co.,LLC | 1977 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | Hu-Friedy | 1977 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLCPLUGGERROOT CANAL | 1977 |
| Preformed CrownELZ · Class 1 | — | Lister | Hu-Friedy Stainless Steel CrownsPEDO CrownsZirconia Crowns | 2011 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | HEMOSTATHu-Friedy Mfg Co., LLC | 1998 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1977 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | Hu-Friedy Mfg Co.,LLC | 1998 |
| AirbrushKOJ · Class 2 | — | Lister | HuFriedyGroupPWR AirPWR HandpiecePWR PairSubgingival PWR Perio Tips | 2024 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | Hu-Friedy Mfg. Co., LLC | 2015 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | HuFriedyGroupPWR Classic PowderPWR Perio Powder | 2024 |
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 Hu-Friedy Mfg Co., LLC as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Nov 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | EJI Cartridge Syringe |
| 30 Mar 2010 | K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | ELC Ultrasonic Scaler |
| 27 Feb 2008 | K073369 | EI DOWNPAK BARRIER SLEEVES | EKM Gutta-Percha |
| 21 Jun 2007 | K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | ELC Ultrasonic Scaler |
| 1 Feb 2006 | K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | ELC Ultrasonic Scaler |
| 27 Jul 2001 | K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | ELC Ultrasonic Scaler |
| 7 Oct 1995 | K953919 | DENTAL ULTRASONIC SCALER INSERTS | ELC Ultrasonic Scaler |
| 24 Jul 1991 | K912473 | ACCU-PLACER TM KIT | EKJ Operative Burnisher |
Some of these clearances are listed with FDA today by another company: J&J Instruments (1), Accompany Surgical (1), Goldstar Medical Instruments (1).
Also lists devices cleared under other names
Hu-Friedy Mfg Co., LLC 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: Mectron S.P.A. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 May 2025 | K251425 | turbodent touch | Mectron S.P.A. | KOJ Airbrush |
| 15 May 2023 | K231391 | Combi Touch | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 20 Aug 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HU-FRIEDY MFG CO., LLCFDA reg. 3009968482 | Des Plaines, IL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
| HU-FRIEDY MFG. CO. LLCFDA reg. 1416605 | Northbrook, IL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| HU-FRIEDY MFG. CO. LLCFDA reg. 3005049358 | PUDONG, SHANGHAI, China | Foreign exporter, Manufacturer |
| HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSCFDA reg. 3004193466 | Emmingen-Liptingen Baden-Wurttemberg, Germany | Foreign exporter, Repacker / relabeler |
Other names on FDA records
Hu-Friedy MFG. Co. LLC Zweigniederlassung Deutsc
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1416605). 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.