Miscellaneous devices · 21 CFR 872 Subpart G

Saliva Ejector Mouthpiece

FDA device type “Mouthpiece, Saliva Ejector”.

FDA codeDYNClass121 CFR872.6640Pathway510(k) exempt
Companies listing it
146107 makers
Brands and models
192
510(k) clearances
180 in five years
FDA name
Mouthpiece, Saliva Ejector
1976: 21978: 11980: 21986: 41987: 21990: 11992: 21993: 11994: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list DYN

146 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Ivoclar Vivadent, AGUnited StatesMakerOptraGate Dry Control942026
Cefla S.C.ItalyMakerWS Aerosol Defender152026
Inter-Med, Inc.United StatesMakerVista Disposable HVE Screens72026
Ttbio Corp.TaiwanMaker—62023
Premium Plus (Dongguan) LimitedChinaMakerSaliva ejectors22025
A-dec, Inc.United StatesMakerSaliva Ejector (SE) · Saliva Ejector (SE) tip682022
Pacific Care LimitedHong Kong SAR ChinaMakerPracticon / IndiGreen Innovations12025
Jiangsu Dynamic Medical Technology Co., LtdChinaMakerSaliva Ejector12023
Worldwork S.R.LItalyMakerMouthpiece, saliva ejector12023
Angelus Industria DE Produtos Odontologicos S/ABrazilMakerFlex Endodontic Ejector · Flex Kids Ejector · Flex Saliva Ejector · Flex Surgical Ejector112021
Rolence Ent., Inc.TaiwanMakerSALIVA EJECTOR52009
Premium Plus International LimitedHong Kong SAR ChinaMakerDentmas · Disposable Saliva Ejectors32017
Beaverstate Dental, Inc.United StatesMaker112-262 HVE VALVE STANDARD · 112-263 HVE VALVE UNIVERSAL · 112-280 SALIVA EJECTOR VALVE21995
Hager Worldwide, Inc.United StatesMakerBio Vacuum Tip · Comfi-Tips · Mirasucto · Mirror Suction · +622005
J.H.Orsing ABSwedenMakerHygoformic Bio · Hygoformic L · Hygoformic U · Soft adapter · +111994
BiosealUnited StatesMakerSaliva Ejector11988
Guilin Yikeshi Medical Instrument Co LtdChinaMakerSalivary Tube——
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakerMouthpiece, Saliva Ejector——
Huanghua Promisee Dental Co., LtdChinaMakerDry Field SystemTubing · Endodontic Aspirator Tip · Saliva ejector · Smart Saliva Ejectors——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerMouthpiece, Saliva Ejector——
Shanghai Alwings Medical Instrument Co.,Ltd.ChinaMakerEvacuator Tip · Saliva Ejector · Surigcal Aspirator Tip——
SPS/Crosstex InternationalUnited StatesMakerAdvantage Saliva Ejector · Comfort Plus Premium Saliva Ejector · PREMIUM SALIVA EJECTORS · Safe-Flo adaptor M1020ADAP · +5——
Shanghai Dochem Industries Co., Ltd.ChinaMakerevacuator tips · Saliva ejector · Surgical aspirator tips · Tip Inserts/ Jet Inserts/ Surge Inserts——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerMouthpiece, saliva ejector——
Lacigrus InternationalPakistanMakerMouthpiece, saliva ejector——
Shanghai Lions Industrial Co., Ltd.ChinaMakermouthpiece, saliva ejector——
Beyes Dental IncCanadaMakerBeyes Mouthpiece, Saliva Ejectors——
Great Lakes Dental Technologies, Ltd.United StatesMakerNola Dryfield System and accesories——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMakerSaliva Ejectors——
ZOGEAR Medical Co., Ltd.ChinaMakerMouthpiece, saliva ejector——
W.H. Holden Inc. DBA H & H CompanyUnited StatesMakerSALIVA EJECTOR——
Anqing Clean Dental Instrument Technology Co LtdChinaMakerSaliva ejector——
Hubei Guarddent Medical Technology Co.,LtdChinaMakerSaliva Ejectors——
BH Medical Products Co., LtdChinaMakeraspirator tip · HVE tip · saliva ejector——
NuCare LLCUnited StatesMakerHVE Tips · Saliva Ejector · Surgical Aspirator Tips——
Cangzhou Lankang Medical Instruments Developing Co., Ltd.ChinaMakerSaliva Ejector——
Guangzhou Xinuo Technology Co., LtdChinaMakerMouth Props, Endo Measure Block;Endo Clean Block——
Jiangsu Yabaobao Medical Instrument Co.,Ltd.ChinaMaker———
Shenzhen Senlede Technologies Co., LtdChinaMakerMouth Props, Endo Measure Block;Endo Clean Block——
READY SET IMPORT dba Mynt ProfessionalUnited StatesMakerRSI Saliva Ejector——
TF New Material Sci and Tec Co.,ltdChinaMakerSaliva ejector · Suction tips——
Hefei Xingcheng Sanitary Products CO.,LTDChinaMakerSaliva ejector · Sugical tip/ HV TIP · Surgical tip——
HuangHua DK Dental Co., LTD,ChinaMakerSaliva Ejector,Surgical aspirator tip,vented oral Evacuation tip——
Henan Baistra Medical Devices LimitedChinaMakerMouthpiece, saliva ejector——
Svenska Dentorama ABSwedenMakerDENTORAMA ASPIRATOR TUBES · DENTORAMA SALIVA EJECTORS——
Zirc Dental Products IncUnited StatesMakerMr. Thirsty One-Step, Mr. Thirsty One-Step Comfort Kit · Pink Petal · SE Cushions, Lingua-Fix, Saliva Ejector, Saliva Ejector Valve, Saliva Ejector Tip——
Zhejiang Yamei Medical Equipment Technology Co., Ltd.ChinaMakerSaliva Ejector——
Huzhou Junda Industry Co., Ltd.ChinaMakerDental Saliva Ejector——
Xiantao S&J Protective Products Co., LtdChinaMakerMouthpiece, Saliva Ejector——
Dentech Corp.JapanMakerMOUTHPIECE, SALIVA EJECTOR——
Hefei Mlush Sanitary Products Co., LtdChinaMakersaliva ejector,suction tips——
Hubei Qianjiang Kingphar Medical Material Co LtdChinaMakersaliva ejectors——
Tianjin Water Source Tech Co., Ltd.ChinaMakerMouthpiece, Saliva Ejector, Plastic Tubes——
Shandong Zhushi Pharmaceutical Group Co., LtdChinaMakerMOUTHPIECE, SALIVA EJECTOR——
Plasdent Shanghai Co., Ltd.ChinaMakerAbsorber, Saliva, Paper, Paper Bibs, Paper Tray Covers——
Jinyuan medical equipment(tianjin)co.,ltdChinaMakerSaliva Ejector——
Wellmed Dental Medical Supply Co., Ltd.ChinaMakerMOUTHPIECE, SALIVA EJECTOR——
Cordica Medical (Formally Team Technologies, Inc)United StatesMaker———
Shengiho Enterprise Co., Ltd.TaiwanMakerPLASTIC TUBES · PLASTIC TUBES, ASPIRATING TIPS, SALIVA EJECTORS · SALIVA EJECTOR——
Zhejiang Mediunion Healthcare Group Co LtdChinaMakerEvergrand Saliva Ejector——
Atria Co.South KoreaMakerAtria——
Zyris, Inc.United StatesMakerIsolite Mouthpiece——
Euronda SPAItalyMakerMONOART EM15 SALIVA EJECTOR——
Jujiang Huada Medical Dressing Co., Ltd.ChinaMakerSALIVA EJECTOR——
ASA DentalItalyMakerSALIVA EJECTOR DISPOSABLE——
Yongqing Huaguan Dental Instruments FactoryChinaMakerMouthpiece, Saliva Ejector——
Hefei Jingcheng Plastic Products Co. LtdChinaMakerSaliva Ejector · Santi Tip——
Anhui JM Healthcare Products Co.,Ltd.ChinaMakerSaliva Ejector, HIGH VOLUME EVACUATORS, ASPIRATING TIPS, Prophy Angles——
Dacheng Huaguan Dental Instruments Co., Ltd.ChinaMakerMouthpiece · Plastic Tubes · Saliva Ejector——
Yueying Medical Instruments (Langfang) Co., Ltd.ChinaMakerMouthpiece, Saliva Ejector——
Anhui Ares Medical Technology Co.,Ltd.ChinaMakersaliva ejector——
Changzhou Shengkang Medical Instrument Co.,LTDChinaMakerDisposable dental saliva ejector——
Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.BrazilMakerINDUSBELLO——
Shanghai Greeloy Industry Co., LtdChinaMakerSaliva Ejector——
Anhui MedPurest Medical Technology Co LtdChinaMakerSaliva Ejector——
Dongguan Yilong Medical Supplies Co., Ltd.ChinaMakersurgical suction tips——
Greatcare 4u sdn bhdMalaysiaMakerDisposable saliva ejector——
Zhejiang Lidesen Medical Instrument Co., LtdChinaMakerSALIVA EJECTOR——
Anqing Kangmingna Packaging Co.,LtdChinaMakerSaliva Ejector——
Ascentcare Dental ProductsUnited StatesMakerVacuLUX Mouthpiece——
Hangzhou Rollmed Co.,Ltd.ChinaMakersaliva ejector——
Dongguan Ouwen Medical Device Technology Co., Ltd.ChinaMakerSALIVA EJECTOR——
Shioda Dental Co.JapanMakerSHIODA——
TianJin Jieyaxin Medical Plastic Equipment Co., Ltd.ChinaMakersaliva ejector——
Weihai Xingtai Packaging Products Co., Ltd.ChinaMakerSaliva ejector——
Anji SPENQ Industrial Co., Ltd.ChinaMakerSALIVA EJECTOR——
Larident SRLItalyMakerCannula Zero Saliva Ejector——
NINGBO Chibanda IMP &EXP CO, LTDChinaMakersaliva ejectors——
Jin Hsiang Enterprise Co., Ltd.TaiwanMaker———
SFS Group Schweiz AG, KunststoffwerkSwitzerlandMakerOptraGate Dry Control——
SMD Solution Co., Ltd.South KoreaMakerCOMORAL Oral Irrigation Unit——
BGSS Company Asia LimitedChinaMaker———
Changzhou Care-De Sanitary Material Co., Ltd.ChinaMakerSALIVA EJECTORS——
Changzhou Hongtai Paper Film Co LtdChinaMakerSALIVA EJECTORS——
Changzhou Shengjie Medical Product Co., LtdChinaMakerSaliva tips ,Evacuator tips, Surgical tips——
Cross Protection M Sdn. Bhd.MalaysiaMakerCross Protection Saliva Ejector · Cross Protection Saliva Ejector Tip——
Hubei V-Medical Products Co., Ltd.ChinaMakerSaliva Ejector——
Solmetex, LLCUnited StatesMakerDryShield——
Ultralight Optics Inc.United StatesMakerAutoDam——
Eg-Medacys Devices(Shenzhen)co.,ltdChinaMakerMOUTHPIECE,SALIVA EJECTOR——
Excel Medical Products, Inc.United StatesMaker———
NuFlow Products CorporationUnited StatesMakerNuFlow——
Shenzhen Kingod Silicone Rubber Products Co.,LtdChinaMakerSaliva Ejector Mouthpiece——
Suzhou PurePower Medical Technology Co.,LtdChinaMakerNuFlow——
Cardinal Health 200, LLCUnited StatesMaker———
Icp, Inc.United StatesMaker———
Saliva SystemsUnited StatesMaker———
Young Innovations IncUnited StatesContract manufacturerOrthodontics Products, Tongue Guards232025
Keystone IndustriesUnited StatesContract manufacturerFlexo Disposable Saliva Ejectors · Prehma Saliva Ejectors22025
DB Orthodontics LimitedUnited KingdomForeign exporterNola Dry Field System22010
Rmo, Inc.United StatesManufacturerRMO Mouthgaurd11990
One DashcorpUnited StatesRepacker / relabelerValdent USA PVC Saliva Ejectors, Assorted 100/Pk · Valdent USA PVC Saliva Ejectors, Blue/Clear 100/Pk · Valdent USA PVC Saliva Ejectors, Clear/Blue 100/Pk · Valdent USA PVC Saliva Ejectors, Clear/Pink, 100/Pk · +1——
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributorAIR WATER SYRINGE TIP · DENTAL SALIVA EJECTOR · DENTAL SUCTION TIP · saliva ejector · +2——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerToscana——
TitanLinks Logistics LLCUnited StatesRepacker / relabeler———
Jmu Dental, Inc.United StatesRepacker / relabelerSALIVA EJECTOR, EVACUATOR TIPS——
Patterson Companies, Inc.United StatesForeign exporterBraval Saliva Ejectors——
Premium Plus DentalUnited StatesListerPremium Plus Saliva Ejector——
Ortho Arch Company IncUnited StatesRepacker / relabelerCottonmouth Dry Field System——
Yizur LtdHong Kong SAR ChinaForeign exporterSaliva Ejector——
CARGUS International Inc.United StatesRepacker / relabelerMARK3® Saliva Ejectors · MARK3® Surgical Aspirating Tips——
AMD Medicom IncCanadaForeign exporterHedy Saliva Ejectors · Medicom High Suction Tips · Medicom Saliva Ejectors——
Shanghai MU PROMOTIONS Co., Ltd.ChinaForeign exporterMouthpiece, Saliva Ejector——
Shanghai smedent medical instrument co., ltd.ChinaForeign exporterProduct: DYN - Mouthpiece, saliva ejector, saliva ejector tips, evacuator tips, aspirator tips——
Plasdent CorporationUnited StatesRepacker / relabelerMOUTHPIECE, SALIVA EJECTOR, PLASTIC TUBES, ASPIRATOR TIPS——
Boen Healthcare Co LtdChinaForeign exportermouthpiece; saliva ejector——
US Orthodontic ProductsUnited StatesRepacker / relabelerSaliva Ejector——
Dongguan Wanjin Industrial Co., LtdChinaManufacturerSaliva Ejector——
ATOMO Dental, Inc.United StatesRepacker / relabelerSaliva ejector, Evacuator tips——
Dukal CorporationUnited StatesSpecification developerSaliva Ejectors(Multiple Private Label Brands)——
Midwest DentalUnited StatesRepacker / relabeler———
Shanghai Hua EN Industrial Co. Ltd.ChinaForeign exporter———
Palmero HealthcareUnited StatesRepacker / relabelerSaliva Ejector Screen——
Omnia SRLUnited StatesContract manufacturerSplitAir——
Trinity Sterile IncUnited StatesManufacturerAspirator——
Universal Orthodontic Lab, Inc.United StatesManufacturerSaliva Ejector——
Tianjin Medicines & Health Products Imp. & Exp. Corp.ChinaForeign exporterMOUTHPIECE, SALIVA EJECTORS, PLASTIC TUBES——
Evolve Dental Technologies, Inc.United StatesRepacker / relabelerKöR Oral Suction Tip——
VastMEd LLCUnited StatesRepacker / relabelerVASTMED Mouthpiece, saliva ejector——
CBR Enterprise LimitedHong Kong SAR ChinaForeign exporter———
Kash Sales Inc.CanadaForeign exporter———
Olulo LLCUnited StatesRepacker / relabeler———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Bright Supply IncUnited StatesLister———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
17 Aug 1994K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflex
21 Mar 1994K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing AB
21 Mar 1994K935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.
31 Mar 1993K924211EJECTORGlenroe Technologies
11 May 1992K920492HIGH VACHygoplastic, Inc.
5 May 1992K921117MINIDAMDelsan Dental Systems
4 Apr 1990K900631SALIVA ABSORBER - DENTALKab Gloves Unltd.
15 Apr 1987K871315ORAL ASPIRATOREndovations
23 Mar 1987K870599TIP, DENTAL SUCTION APPARATUSMilitary Engineering, Inc.
24 Nov 1986K864300SILIVA EJECTOR/ORAL CAVITY EVACUATORArdent Intl., Inc.
27 Oct 1986K863768SALIVA EJECTORSThe Medical Group, Inc.
22 Sep 1986K863163ULS 8-86American Instrument Manufacturer'S, Inc.
9 Jun 1986K861934SALIVA EJECTORCarlisle Laboratories, Inc.
14 Nov 1980K801927SILENTSLEEPSlumber Research, Inc.
6 Feb 1980K800210TONGUE HOLDER/SALIVA EJECTORUnitek Corp.
4 Dec 1978K781592SURGICAL ASPIRATOR TIPSHenry Schein, Inc.
23 Dec 1976K761264OPTIONS FOR STAR DENTAL OPUS ISyntex Corp.
21 Sep 1976K760620SALIVA EJECTORLorvic Corp.

Official records: FDA product classification for DYN · 21 CFR 872.6640.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026