FDA.reportPublic FDA data

Dental material injection cannula, single-use

Definition
A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.
GUDID devices
754
Last updated
2026-10-06 03:49:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10810000525802Predicta®PARKELL, INC.S6512026-09-25
08809518346721Disposable TipMEDICLUS CO.,LTD650032252026-06-05
00810194403293AiraAIRA, LLC1006252026-08-25
00810194403309AiraAIRA, LLC1006262026-08-25
00810194403323AiraAIRA, LLC1006282026-08-25
00810194403330AiraAIRA, LLC1006292026-08-25
00840456202555JMUJMU DENTAL, INC465010062026-07-27
00840456202562JMUJMU DENTAL, INC465010072026-07-27
00840456202579JMUJMU DENTAL, INC465010082026-07-27
00840456202586JMUJMU DENTAL, INC465010092026-07-27
00840456202593JMUJMU DENTAL, INC465010102026-07-27
00840456218006JMUJMU DENTAL, INC465010112026-07-27
00840456218013JMUJMU DENTAL, INC465010122026-07-27
00840456218020JMUJMU DENTAL, INC465010132026-07-27
00840456218037JMUJMU DENTAL, INC465010142026-07-27
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFT7608162026-07-14
D1250802Premium PlusPremium Plus (Dongguan) Limited0802026-05-27
D1250812Premium PlusPremium Plus (Dongguan) Limited0812026-05-27
D1250822Premium PlusPremium Plus (Dongguan) Limited0822026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedYS10012026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedYS10022026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedYS10072026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedYS10122026-05-27
00195062076374ZenSealKerr Corporation825-95022023-09-01
00359883007218EVANESCEDEN-MAT HOLDINGS, LLC0322202025-10-08
00371347005042Advance Dental ProductsThe Atlanta Dental Supply Company312100-282023-02-10
00371347005059Advance Dental ProductsThe Atlanta Dental Supply Company312102-282023-02-10
00371347005073Advance Dental ProductsThe Atlanta Dental Supply Company312105-282023-02-10
00371347005080Advance Dental ProductsThe Atlanta Dental Supply Company312200-282023-02-10
00371347005158Advance Dental ProductsThe Atlanta Dental Supply Company316133-282023-02-10
00371347005165Advance Dental ProductsThe Atlanta Dental Supply Company316137-282023-02-10
00371347005172Advance Dental ProductsThe Atlanta Dental Supply Company316139-282023-02-10
00371347005189Advance Dental ProductsThe Atlanta Dental Supply Company321400-282023-02-10
00371347005196Advance Dental ProductsThe Atlanta Dental Supply Company321610-282023-02-10
006522211089993M™3M UNITEK CORPORATION712-0372022-12-08
006522212875023M™3M UNITEK CORPORATION712-0452022-12-08
006522213074533M™ Clarity™3M UNITEK CORPORATION359-6322026-04-25
008171690246063D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCIO-CL2023-01-11
008171690246133D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCIO-Y2023-01-11
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCASK2026-04-03
00843471100318Obtura SpartanYoung Innovations, Inc.823-6202022-10-06
00843471100349Obtura SpartanYoung Innovations, Inc.823-6232022-10-06
00843471100370Obtura SpartanYoung Innovations, Inc.823-6352022-10-06
00883205033086NaviTip 29G SideportULTRADENT PRODUCTS, INC.49892022-12-08
00883205033093NaviTip 29G SideportULTRADENT PRODUCTS, INC.49902022-12-08
00883205033109NaviTip 29G SideportULTRADENT PRODUCTS, INC.49912022-12-08
00883205033116NaviTip 29G SideportULTRADENT PRODUCTS, INC.49922022-12-08
00889813002803Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95190652022-05-02
00889813048030Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95035302022-05-02
00889813052044Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC52519362021-06-30
03760243000720Expasyl cannulasACTEON MANUFACTURINGEXPASYL2022-09-20
03760243000737Expasyl cannulasACTEON MANUFACTURINGEXPASYL2022-09-20
03760243000744Expasyl cannulasACTEON MANUFACTURINGEXPASYL2022-09-20
03760243000751Expasyl cannulasACTEON MANUFACTURINGEXPASYL2022-09-20
04035077002028RelyX™ Unicem Aplicap™3M Deutschland GmbH568162017-08-04
04035077002035RelyX™ Unicem Aplicap™3M Deutschland GmbH568172017-08-04
040350770030943M™ RelyX™3M Deutschland GmbH775502022-08-29
04035077004985RelyX™ Unicem 2 Automix3M Deutschland GmbH568592017-08-04
04035077007030RelyX™ Unicem 2 Automix3M Deutschland GmbH568572017-08-04
04035077007047RelyX™ Unicem 2 Automix3M Deutschland GmbH568482017-08-04
04035077007825Imprint™ 4 Penta™ Heavy3M Deutschland GmbH714972017-08-04
040545965396793M™ Scotchbond™3M Deutschland GmbH412742022-09-19
040545967735613M™ Garant™3M Deutschland GmbH714622022-08-29
040545967735853M™ Garant™3M Deutschland GmbH71461N2022-08-29
040545967736153M™ Garant™3M Deutschland GmbH714602022-08-29
040545968757083M™ RelyX™3M Deutschland GmbH775502023-07-07
040640350654853M™3M Deutschland GmbH712252023-02-24
04548190122714PALFIQUE ESTELITE LV Syringe TipTOKUYAMA DENTAL CORPORATION122712022-09-23
04548190137992TOKUYAMA Plastic TipTOKUYAMA DENTAL CORPORATION137992022-09-23
04548190346554NOZZLE FOR MINI MIXING TIPTOKUYAMA DENTAL CORPORATION346552022-09-23
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFT6698382023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFT5973152023-03-23
07649988072451OdneFill TipOdne AGE-80002024-02-01
10190886000526ETCHANT SYRINGE TIPS FOR BSET15G & H Wire Company, Inc.BSETIPS2016-10-03
10190886000724TIP-REPLACEMENT GEL 22 GA 50PKG & H Wire Company, Inc.M980R-012016-10-03
10190886010730OCS ETCH GEL SYRINGEG & H Wire Company, Inc.008-0312017-01-06
10304040020385Henry ScheinHENRY SCHEIN, INC.10228232020-12-28
10304040051457Henry ScheinHENRY SCHEIN, INC.11259802020-12-28
10304040051464Henry ScheinHENRY SCHEIN, INC.11259812020-12-28
10304040051471Henry ScheinHENRY SCHEIN, INC.11259822020-12-28