Manufacturer registered with FDA

J&J Instruments

Northbrook, IL, United States. Lists 45 dental device types with FDA across 1 registered establishment.

FDA owner/operator2246990Specification developer
Device types listed
45
Brands and models
6
510(k) clearances
0as applicant
Markets registered in
310 registrations outside the US
Establishments
1United States

Registered in 3 markets

Where regulators' registries name J&J Instruments as the manufacturer or the registration holder of a device.

All markets
United States: 45 device types listedBrazil: 7 registrationsIsrael: 3 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerJ&J Instruments45 device types—Below
BrazilANVISAManufacturerJ&J INSTRUMENTS, LLC72017–2018Pure Global AI
IsraelAMARManufacturerJ&J Instruments, LLCJ & J INSTRUMENTS, LLC3—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 J&J Instruments currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
OPENING AND PLACER TOOL
2008
Amalgam Dental CapsuleDZS · Class 1—Maker
Julius Wirth
2019
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2008
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker—2008
Orthodontic Bracket AlignerECQ · Class 1Dental hand instrumentsMaker—2008
Orthodontic Band SetterECR · Class 1Dental hand instrumentsMaker—2008
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—2007
Rubber Dam ClampEEF · Class 1Rubber dam systemsMaker—2010
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—2012
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—2012
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2012
Preformed Impression TrayEHY · Class 1Impression traysMaker—2012
Rubber DamEIE · Class 1Rubber dam systemsMaker—2012
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker—2017
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2012
Dental Wax CarverEIK · Class 1Dental hand instrumentsMaker—2012
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker—2012
Crown RemoverEIS · Class 1Dental hand instrumentsMaker—2012
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—2012
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker—2012
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2012
Cartridge SyringeEJI · Class 2Dental needles & syringesMaker—2013
Operative PliersEJY · Class 1Dental hand instrumentsMaker—2012
Operative Margin Finishing KnifeEJZ · Class 1Dental hand instrumentsMaker—2009
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker—2012
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—2012
Operative Cutting InstrumentEKD · Class 1Dental hand instrumentsMaker—2012
Operative CuretteEKE · Class 1Dental hand instrumentsMaker—2012
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker
CarverCleoid DiscoidJ&J Instruments
2017
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsMaker—2012
Operative BurnisherEKJ · Class 1Dental hand instrumentsMaker—2012
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesMaker—2008
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker—2012
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—2012
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2012
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—2007
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2012
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2008
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—2012
Periodontic KnifeEMO · Class 1Dental hand instrumentsMaker—2009
Periodontic HoeEMQ · Class 1Dental hand instrumentsMaker—2009
Periodontic CuretteEMS · Class 1Dental hand instrumentsMaker—2012
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker—2012
Tongue ScraperLCN · Class 1—Lister—2008
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Julius Wirth
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

J&J Instruments 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: Hu-Friedy Mfg Co., LLC (1).

Decided510(k)DeviceApplicantDevice type
6 Nov 2012K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg Co., LLCEJI Cartridge Syringe

Registered establishments

EstablishmentLocationWhat it does
J & J INSTRUMENTS, LLCFDA reg. 2246990Northbrook, IL, United StatesComplaint file establishment, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2246990). 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.