Manufacturer registered with FDA
Young Innovations Inc
Algonquin, IL, United States. Lists 115 dental device types with FDA across 7 registered establishments, and holds 23 510(k) clearances as applicant.
- Device types listed
- 115
- Brands and models
- 247
- 510(k) clearances
- 231977–2025
- Markets registered in
- 8285 registrations outside the US
- Establishments
- 7United States
510(k) clearances per year, 1976–2026
Registered in 8 markets
Where regulators' registries name Young Innovations 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 | Young Innovations Inc | 23 clearances | 1977–2025 | Below |
| Canada | Health Canada | Registration holder | PREAT CORPORATIONSALVIN DENTAL SPECIALTIES, LLC | 169 | 2012–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SALVIN Dental Specialties, INC.Salvin Dental Specialties, Inc. · SALVIN Dental Specialties, INc. · +2 | 75 | 2003–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SALVIN DENTAL SPECIALTIES, INC.AMERICAN EAGLE INSTRUMENTS · AMERICAN EAGLE INSTRUMENTS INC. · +2 | 20 | 2006–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AMERICAN EAGLE INSTRUMENTS, INCSALVIN DENTAL SPECIALTIES, INC. · AMERICAN EAGLE INSTRUMENTS · +2 | 7 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AMERICAN EAGLE INSTRUMENTSAMERICAN EAGLE INSTRUMENTS INC · YOUNG MICROBRUSH LLC | 6 | 2022–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AMERICAN EAGLE INSTRUMENTS INC.YOUNG INNOVATIONS INC. | 4 | 2015–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Young Innovations IncAmerican Eagle Instruments Inc. · YOUNG MICROBRUSH LLC | 4 | — | 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 Young Innovations 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Implant Prosthetic ComponentsPreatPreat AbutmentsPreatLoc | 2016 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Athena 20R E Type MotorAthena Champion Reusable Prophy AngleAthena High Speed Handpiececontra angle handpiece attachmentJohnson PromidentJohnson Promident, Challenger, ClassicLittle Guy/Little ProProphyPalYoung Hygiene Handpiece | 2007 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | DEL ULTRASONIC TIPSDiamond Coated TipJohnson Promident Ultrasonic InsertsKerr Ultrasonic Diamond TIpsKerr Ultrasonic TIpsObtura Ultrasonic Tips | 2007 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Preat Abutments | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | AEI Dental Hand InstrumentsContactPro SmartBandDental Matrix BandFlap InstrumentsHo BandNitrile Gloves | 2012 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | AmpliDermAMPLIFI Long Term MembraneOraMEM® Plus Resorbable Collagen MembraneRenovixXymphony | 2016 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Salvin Dental Fixation ScrewSalvin Dental Specialties Bone Tack SystemSalvin Tenting ScrewsSalvin Titanium Mesh | 2008 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | AEI Cone Socket MirrorsDENTICATOR DISPOSABLE MOUTH MIRROR | 1992 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Johnson PromidentLatch Type and Straight HandpieceMandrelProphylaxis AnglesYoung Core DPAs | 2007 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | Panoramic | 2022 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dispensing TipsFlowthruImplantlink TipsImpression MaterialIvoclar Soto LC Dispensing Tip Flocked MetalMixing TipsSalvin Graft Syringe, Curved, Stainless SteelSyringe, Restorative and | 2010 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | AEI Mirror HandlesAEI Quik Tip HandlesIvoclar OptrasticksMicrostix | 1992 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Cadre Bur 5 | 2001 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | AEI PluggersObtura III MaxObtura MaxPackObtura Spartan | 1992 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Flowable CompositePIT & FISSURE SEALANTPut & Fissure Sealant Light Curing | 2018 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Biofree TipBiofree Tip; Crystal Tip; Natures Tip; Starz TipzCrystal TipNatures TipPro-Tip & ConvertersStarz TipzUNIT, SYRINGE, AIR AND/OR WATER- Astek | 2018 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Biotrol Surgical Evacuation TipsVented Oral Evacuation TipsYoung Dental High Volume Evacuator Tips | 2001 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | Obtura SpartanS-Kondensers | 2007 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Benco Dry AngleDri-AidDry TipsMicro AnglePatient BibsZooby Pediatric Bibs | 2009 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | D-Lish 5% Sodium Fluoride Varnish - AssortedD-Lish 5% Sodium Fluoride Varnish - Fresh MelonD-Lish 5% Sodium Fluoride Varnish - Green AppleD-Lish 5% Sodium Fluoride Varnish - Spearmint SurpriseD-Lish 5% Sodium Fluoride Varnish - Vanilla CupcakeOral-B 5% Sodium Fluoride VarnishPrivate Labeled 5% Sodium Fluoride VarnishVarnish America - 5% Sodium Fluoride VarnishVarnish Pen 5% Sodium FluorideZooby Fluoride Varnish | 2010 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Panoramic | 2022 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | FULFILL Socket Preservation PlugSalvinOSSSalvinOSS Collagen | 2024 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Johnson Promident Reamers, Post Drills | 2016 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Lister | American Flag Class III Adjustable FacemaskFlames Class III Adjustable FacemaskHawaiian Print Class III Adjustable FacemaskLeopard Print Class III Adjustable FacemaskMulti-Adjustable FacemaskSafety Release Modules HeavySafety Release Modules LightSafety Release Modules Medium | 2018 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | Johnson Promident Polishers, Finishing Srips | 2001 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Flowable CompositeUniversal Composite | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | Impression TraysMATERIAL, IMPRESSION TRAY, RESIN- Astek | 2016 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Band PushersLigature Tucking InstrumentsThe Ortho Store Pushers, Directors, Tuckers | 2020 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2012 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Surgical Instruments - Scissors | 2001 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | BRUSHES AND POLISHERSDISPOSABLE PROPHYLAXIS CUPSPrpphy Angles | 1992 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Cheek RetractorDefend Lite**DISPOSABLE**CK-X-PANDER | 2001 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Cuff Height Measuring ToolTITANIUM IMPLANT DEPTH GAUGE | 2001 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | AEI ProbesPerio Probe | 2012 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | AEI Composite Instruments | 2012 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Biotrol Prophylaxis PasteDenticator Prophylaxis PasteFIRST CHOICE PROPHY COARSE CHERRY 67PKFIRST CHOICE PROPHY COARSE MINT 67PKFIRST CHOICE PROPHY MEDIUM CHERRY 67PKFIRST CHOICE PROPHY MEDIUM STRAWBERRY 67PKFIRST CHOICE PROPHY PASTE BAGS/67 MEDIUM MINTFIRST CHOICE PROPHY PASTE COARSE CHERRY / STRAWBERRY / MINTFIRST CHOICE PROPHY PASTE COARSE CHERRY BOX/ 200FIRST CHOICE PROPHY PASTE COARSE STRAWBERRY BOX/ 200 11 moreFIRST CHOICE PROPHY PASTE FINE BUBBLE GUM BOX/ 200FIRST CHOICE PROPHY PASTE MEDIUM BUBBLE GUM BOX/ 200FIRST CHOICE PROPHY PASTE MEDIUM CHERRY / STRAWBERRY / MINTFIRST CHOICE PROPHY PASTE MEDIUM CHERRY BOX/ 200FIRST CHOICE PROPHY PASTE MEDIUM STRAWBERRY BOX/ 200FIRSTCHOICE PROPHY COARSE STRAWBERRY 67PKPrivate Labeled Prophy PastePROPHY PASTEPROPHY PASTE COARSE BUBBLE GUM BAG / 200PROPHY PASTE COARSE CHERRY BAG / 200Young Dental Prophylaxis Paste | 2002 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | AEI Excavators | 2022 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Johnson Promident Posts | 2016 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Alginate flavoringsMydent - Impression and Bite Material | 2018 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | AEI Surgical Instruments Dental Rongeurs | 2001 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Salvin Dental ElevatorsSurgical Instruments - Hand Instrument | 2013 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | Surgical Instruments - Chisel | 2001 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | AEI Double GraceysAEI Implant InstrumentsAEI Quik TipsAEI ScandetteAEI Talon ToughAEI XP Technology | 1992 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | DESENSITIZER 10MLETCH-GEL 38% KIT | 2018 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Fluoride TraysOral-B Centrays Disposable Fluoride Applicator TraysOral-B Centwins Disposable Fluoride Applicator Trays | 2006 |
| AirbrushKOJ · Class 2 | — | Lister | Airbrush - JetpolisherAirbrush - Miniblaster | 2021 |
| Resin ApplicatorKXR · Class 1 | — | Maker | ESPE/Bisco/Flowthru/Ultradent/TokuyamaMicro ApplicatorsMicrobrushMicrobrush XMicrotipUltrabrushUltratip | 2010 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | FULFILL Socket Preservation PlugSalvin Orastruct | 2012 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BONE-SCRAPERMICRO-BLK-TUNNELPTTorque Driver | 2016 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | Accent BracketsBracket | 2022 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | Barrier SleevesSalvin Disposable Sterile Self Stick Light Handle Covers | 2018 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | AllosculptAlloSculpt 3D Plus | 2017 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | Disclosing Solution, Disclosing TabletsPlak Duo Tone Disclosing Tablets | 2023 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Adhere" Enamel Etch ConditionerAdhere" Light Cure Adhesive 5g SyringeAdhere" Light Cure Adhesive KitAdhere" Light Cure Adhesive PrimerAdhere" Light Cure Adhesive TipsAdhere" Self Cure ActivatorAdhere" Self Cure Adhesive 5g SyringeAdhere" Self Cure Adhesive KitAdhere" Self Cure Adhesive TipsLocktight" Auto Mix Band Cement Blue 1 moreLocktight" Auto Mix Band Cement Natural | 2018 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | Leone Series | 2022 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Orthodontics Products, Tongue Guards | 2017 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Lister | Orapro and Avair Brackets | 2026 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | Orthodontics Springs and Wires | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Orthodontics, Tube | 2017 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | — | 2023 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Lister | — | 2001 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Temporary Crown and Bridge Maerial | 2018 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | — | 2020 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | — | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Orthodontics Products | 2017 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | Orthodontics Springs | 2017 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | Aligner Seaters | 2024 |
| Disk GuardEEJ · Class 1 | — | Lister | Disc Guard | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | Surgical Instruments - Forceps | 2025 |
| Roll CottonEFN · Class 1 | — | Lister | — | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | — | 2020 |
| All Precision AttachmentEGG · Class 1 | — | Maker | — | 1986 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | barrier sleeves and films | 2018 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | The Ortho Store & Johnson Promident Diamond Discs & Strips | 2020 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Johnson Promident | 2021 |
| Preformed BarEHO · Class 1 | — | Lister | — | 2016 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Transform Trays | 2020 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Lister | — | 2001 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | RUBBER DAM HOLDER | 1992 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Orthodontics Products | 2017 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | SYRINGE, CARTRIDGE- Astek | 2023 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Lister | Silver Solder | 2022 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | Salvin Instruments | 2013 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | CX-1 Carr ExplorerDG-16 Endo Explorer | 2016 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | AEI Carvers | 1992 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | AEI Burnishers | 2022 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | AEI Spreaders | 2012 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Obtura gutta percha | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Young Infinity Cordless Handpiece System | 2018 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | — | 2001 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | — | 2001 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | BONE FILE | 2001 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | — | 2001 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | AEI Blackjack (XP)AEI Montana ValueAEI Quik TipsAEI Talon ToughAEI XP Technology | 2012 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Lister | Surgical Instruments - Knife | 2012 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | AEI Periodontic Hoe | 2012 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | RETAINER, MATRIX- Astek19000 Pro-Matrix Narrow Band19001 Pro-Matrix Curve Narrow Band19005 Pro-Matrix Wide Band19006 Pro-Matrix Curve Wide Band | 2021 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Floss | 2008 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | DENTICATOR SPIREX BRUSHES | 1997 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Lister | Salvin Titanium Mesh | 2011 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Lister | Toothbrush Sanitizer Lamp | 2022 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | CytoSurg | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Tray cover | 2018 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Lister | Panoramic | 2022 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Maker | ClearDefense Silver Fluoride Hypersensitivity Varnish | 2025 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Preat Abutments | 2025 |
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 Young Innovations Inc as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 May 2025 | K243824 | Preat Abutments | NHA Endosseous Dental Implant Abutment |
| 28 Feb 2025 | K241041 | Silver Fluoride Hypersensitivity Varnish | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| 26 Oct 2022 | K220823 | Preat Abutments | NHA Endosseous Dental Implant Abutment |
| 18 Mar 2019 | K183518 | Preat Abutments | NHA Endosseous Dental Implant Abutment |
| 20 Aug 2018 | K171377 | Young INFINITY Cordless Handpiece System | EKX Ac-Powered Direct Drive Handpiece |
| 28 Apr 2017 | K161857 | Salvin Tenting Screw System | DZL Intraosseous Fixation Screw |
| 8 Sep 2016 | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | NPK Intraoral Synthetic Barrier |
| 20 May 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH Cavity Varnish |
| 29 Mar 2013 | K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | ELC Ultrasonic Scaler |
| 10 May 2010 | K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | DZL Intraosseous Fixation Screw |
| 26 Mar 2008 | K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | DZL Intraosseous Fixation Screw |
| 18 Mar 2005 | K042972 | XP TECHNOLOGY ULTRASONIC SCALER | ELC Ultrasonic Scaler |
| 15 Apr 1994 | K932255 | YOUNG D'GRANULATOR | KMW Rotary Bone Cutting Handpiece |
| 17 Dec 1990 | K903284 | YOUNG PROPHY SYSTEM, PS UNIT | KOJ Airbrush |
| 10 Jun 1988 | K875340 | JETPOLISHER(TM) | KOJ Airbrush |
| 18 Apr 1988 | K875339 | JETPOLISHER AIRPOLISHING POWDER | EJR Oral Cavity Abrasive Polishing Agent |
| 9 Jun 1982 | K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | EFB Dental Air-Powered Handpiece |
| 13 May 1981 | K810977 | ENDODONTIC POST SYSTEMS | ECG Boiling Water Sterilizer |
| 15 Jun 1979 | K790723 | PROPHYLAXIS CUPS AND POLISHERS | EHK Prophylaxis Cup |
| 15 Jun 1979 | K790722 | PROPHYLAXIS ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 10 Oct 1978 | K781520 | RUBBER DAM HOLDER | EJE Rubber Dam Frame |
| 26 May 1978 | K780752 | PROPHYLAXIS ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 20 Jun 1977 | K770997 | PRO-CARE | JEQ Powered Toothbrush |
Some of these clearances are listed with FDA today by another company: National Dentex LLC (2), Smart Denture Conversions, LLC (1), AMD Medicom Inc (1), Dental Engineering Laboratories (1).
Also lists devices cleared under other names
Young Innovations 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: Prismatik Dentalcraft, Inc. (11), Terrats Medical, S.L. (7), Panoramic Corp. (6), Dmp, Ltd. (5), Collagen Matrix, Inc. (4), Rhein'83 Srl (3), Deldent , Ltd. (3), Athena Technology, Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Apr 2026 | K253804 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2025 | K251547 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 21 Apr 2025 | K251196 | Composite Orthodontic Brackets and Buttons | EC Certification Service GmbH | DYW Orthodontic Plastic Bracket |
| 5 Nov 2024 | K242340 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 1 May 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 27 Oct 2022 | K222288 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Sep 2020 | K193212 | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | NPM Animal Source Bone Grafting Material |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 9 Apr 2018 | K171409 | OT EQUATOR | Rhein'83 Srl | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 6 Jun 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 16 May 2017 | K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | NPM Animal Source Bone Grafting Material |
| 14 Dec 2016 | K160475 | Ritter Dental Implant System | Ritter Implants GmbH and Co. KG | DZE Root-Form Endosseous Implant |
| 7 Jun 2016 | K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation Dba Dsm Biomedical | NPL Intraoral Animal Source Barrier |
| 4 Feb 2016 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | OAS Dental Computed Tomography X-Ray |
| 25 Nov 2015 | K142211 | OT EQUATOR | Rhein'83 Srl | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 1 Oct 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 2 Apr 2015 | K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | DZE Root-Form Endosseous Implant |
| 6 Jan 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 25 Nov 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 13 Nov 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 24 Oct 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 30 Jul 2014 | K141130 | ENCOMPASS | Panoramic Corp. | MUH Digital Extraoral Source X-Ray System |
| 11 Jul 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE | Kensey Nash Corporation | NPL Intraoral Animal Source Barrier |
| 22 Feb 2013 | K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM | Prismatik Dentalcraft, Inc. | DZE Root-Form Endosseous Implant |
| 10 Dec 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 12 Oct 2012 | K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 28 Sep 2012 | K121915 | BRIGHT RESTORATIVE MATERIALS | Dmp, Ltd. | EBF Resin Tooth Shade Material |
| 12 Aug 2011 | K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. | NUN Human Source Bone Grafting Material |
| 29 Jul 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 17 Mar 2011 | K110371 | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY | Panoramic Corp. | MUH Digital Extraoral Source X-Ray System |
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | Danville Materials, LLC | EBG Resin Temporary Crown and Bridge |
| 25 Jan 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | HT Co., Ltd. | NJM Orthodontic Ceramic Bracket |
| 13 Jan 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | Dmp, Ltd. | ELW Impression Material |
| 28 Dec 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 3 Dec 2010 | K102252 | DMP PIT & FISSURE SEALANT | Dmp, Ltd. | EBC Pit and Fissure Sealant and Conditioner |
| 23 Nov 2010 | K102254 | DMP SINGLE BONDING | Dmp, Ltd. | KLE Resin Tooth Bonding Agent |
| 19 Nov 2010 | K102257 | NANOCERAM- BRIGHT | Dmp, Ltd. | EBF Resin Tooth Shade Material |
| 11 Aug 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 15 Mar 2010 | K093122 | MBCP+ | Biomatlante | LYC Synthetic Bone Grafting Material |
| 12 Feb 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | LYC Synthetic Bone Grafting Material |
| 24 Jul 2008 | K080814 | VOCO PROFLUORID VARNISH | Voco GmbH | LBH Cavity Varnish |
| 30 Apr 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. | NUN Human Source Bone Grafting Material |
| 20 Mar 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 7 Feb 2008 | K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | Promident, LLC | EFB Dental Air-Powered Handpiece |
| 12 Oct 2007 | K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | Beijing North Pole Dental Handpiece Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 5 Jun 2006 | K060347 | B&L L-BETA, MODEL WL-B1 | B&L Biotech Co., Ltd. | EKR Endodontic Root Canal Plugger |
| 20 Jul 2005 | K051664 | SCAN300FP / RETROPAN (VDC) | Oy Ajat, Ltd. | MUH Digital Extraoral Source X-Ray System |
| 26 May 2005 | K050669 | JEIL BONE FIXATION SYSTEM | Jeil Medical Corporation | JEY Bone Plate |
| 13 Jan 2005 | K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | Panoramic Corp. | EHD Extraoral with Timer X-Ray Unit |
| 1 Dec 2004 | K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | EKR Endodontic Root Canal Plugger |
| 21 Apr 2004 | K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK | Rhein'83 Srl | DZE Root-Form Endosseous Implant |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 19 Feb 2002 | K014249 | JETPOLISHER | Deldent , Ltd. | KOJ Airbrush |
| 10 Jan 2002 | K013969 | MINIBLASTER | Deldent , Ltd. | KOJ Airbrush |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 Jun 2001 | K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. | ELC Ultrasonic Scaler |
| 13 Nov 2000 | K002521 | SPARTAN MTS | Spartan Marketing Group | ELC Ultrasonic Scaler |
| 9 Jun 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology, Inc. | DZB Orthodontic Extraoral Headgear |
| 13 Mar 1998 | K974670 | ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE | Athena Technology, Inc. | EFB Dental Air-Powered Handpiece |
| 11 Mar 1998 | K974671 | ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR | Athena Technology, Inc. | EFB Dental Air-Powered Handpiece |
| 10 Jul 1996 | K961754 | SAFETY RELEASE MODULE | G&H Wire Company | DZB Orthodontic Extraoral Headgear |
| 3 Oct 1995 | K953504 | MICROPRIME | Danville Engineering, Inc. | KLE Resin Tooth Bonding Agent |
| 15 Dec 1994 | K925678 | ATHENA HIGH SPEED HANDPIECE | Athena Technology, Inc. | EFB Dental Air-Powered Handpiece |
| 25 Feb 1994 | K940120 | ALPHA-DENT | Wallace A. Erickson & Co. | ELW Impression Material |
| 23 Oct 1991 | K914322 | BARITONE C2 & BARITONE L3 | Confi-Dental Products Co. | EBC Pit and Fissure Sealant and Conditioner |
| 6 Aug 1990 | K902075 | INTRIGUE CERAMIC BRACKET | Lancer Orthodontics, Inc. | NJM Orthodontic Ceramic Bracket |
| 4 Aug 1988 | K882436 | LASER - 1000 | Panoramic Corp. | EHD Extraoral with Timer X-Ray Unit |
| 25 Jul 1988 | K881985 | CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP | Denticator | EFB Dental Air-Powered Handpiece |
| 13 Feb 1987 | K870236 | PANORAMIC X-RAY MODEL PC-1000 | Panoramic Corp. | EHD Extraoral with Timer X-Ray Unit |
| 15 Nov 1978 | K781545 | AIR POWERED DENTAL HANDPIECE | Promident Mfg., Ltd. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMERICAN EAGLE INSTRUMENTSFDA reg. 3027615 | Missoula, MT, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
| GENERAL ASSEMBLY & MANUFACTURING CORP.FDA reg. 3002865830 | Cary, IL, United States | Contract manufacturer |
| PREAT CorporationFDA reg. 2918719 | Santa Maria, CA, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
| SALVIN DENTAL SPECIALTIES, LLCFDA reg. 1066741 | CHARLOTTE, NC, United States | Repacker / relabeler, Specification developer |
| YOUNG DENTAL MANUFACTURING CO 1, LLC.FDA reg. 1941138 | EARTH CITY, MO, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| YOUNG INNOVATIONS INC.FDA reg. 2024980 | Algonquin, IL, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
| YOUNG MICROBRUSH LLCFDA reg. 2134751 | GRAFTON, WI, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
American Eagle Instruments, Inc. · Preat Corporation · Salvin Dental Specialties, Inc. · YOUNG DENTAL MANUFACTURING Co. 1, LLC · Young Microbrush LLC · General Assembly & Manufacturing Corp.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028124, 9046427, 9004980, 9031933, 2918719, 9092605, 9038280). 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.