FDA.reportPublic FDA data

Dental delivery system instrument unit, electric

Definition
A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.
GUDID devices
211
Last updated
2026-10-13 01:08:38

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841709109805MidmarkMIDMARK CORPORATION153600-0202026-09-28
00841709109812MidmarkMIDMARK CORPORATION153600-0212026-09-28
00841709109843MidmarkMIDMARK CORPORATION153600-3042026-09-28
00841709109850MidmarkMIDMARK CORPORATION153600-3052026-09-28
00841709109874MidmarkMIDMARK CORPORATION153600-5042026-09-28
00841709109881MidmarkMIDMARK CORPORATION153600-5052026-09-28
00841709110030MidmarkMIDMARK CORPORATION153678CM2026-09-28
00841709110054MidmarkMIDMARK CORPORATION153678WL2026-09-28
00841709110061MidmarkMIDMARK CORPORATION153678WS2026-09-28
00841709111846MidmarkMIDMARK CORPORATION153600-0012026-09-28
00841709111853MidmarkMIDMARK CORPORATION153600-0022026-09-28
00841709110337MidmarkMIDMARK CORPORATION153603LR-E2020-05-22
00841709110344MidmarkMIDMARK CORPORATION153604CE2020-05-22
00841709110375MidmarkMIDMARK CORPORATION153604LRCA-E2020-05-22
00841709110382MidmarkMIDMARK CORPORATION153604LR-E2020-05-22
00841709111839MidmarkMIDMARK CORPORATION153603C2020-05-22
00841709110320MidmarkMIDMARK CORPORATION153603LR2020-05-22
00841709110351MidmarkMIDMARK CORPORATION153604LR2020-05-22
00841709110368MidmarkMIDMARK CORPORATION153604LRCA2020-05-22
00850309007480Standard Triton Self-Contained Delivery SystemsASI MEDICAL, INC.90-26252020-11-13
00858395006653Premolar CrossFire Procedure Instrument with MatrixSONENDO, INC.FG-014-000012020-10-20
00858395006738Posterior Cleanflow MatricesSONENDO, INC.FG-013-000072022-10-25
08809260475656Henry ScheinSaeshin Precision Co., Ltd.Maxima Elite i2026-05-21
08809260475663Henry ScheinSaeshin Precision Co., Ltd.Maxima Elite iL2026-05-21
10858395006476Sealing Cap (Size 5)SONENDO, INC.FG-001-001052019-01-22
10858395006483Sealing Cap (Size 6)SONENDO, INC.FG-001-001062019-01-22
10858395006490Sealing Cap (Size 7)SONENDO, INC.FG-001-001072019-01-22
10858395006506Sealing Cap (Size 8)SONENDO, INC.FG-001-001082019-01-22
10858395006513Sealing Cap (Size 9)SONENDO, INC.FG-001-001092019-01-22
10858395006704Posterior CleanFlow Procedure Instrument with Matrices SONENDO, INC.FG-013-000032022-10-25
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbH302780002023-07-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbH303530002023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbH303580002023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbH303630002023-07-19
00841709122132MidmarkMIDMARK CORPORATION153839-0132026-03-11
00841709122149MidmarkMIDMARK CORPORATION153720-0112026-03-11
00841709122156MidmarkMIDMARK CORPORATION153740-0122026-03-11
00841709122163MidmarkMIDMARK CORPORATION153740-0132026-03-11
00841709122170MidmarkMIDMARK CORPORATION153740-0142026-03-11
00841709121852MidmarkMIDMARK CORPORATIONDS-1100-0012026-02-20
00841709121869MidmarkMIDMARK CORPORATIONDS-1200-0012026-02-20
00841709121876MidmarkMIDMARK CORPORATIONADS-1100-0012026-02-20
00841709121883MidmarkMIDMARK CORPORATIONADS-1200-0012026-02-20
D745701120GLH00010Glidewell™Prismatik Dentalcraft, Inc70-1120-GLH00012025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, Inc70-1120-GLH00022025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, Inc70-1120-GLH00032025-11-24
07649988156632OdneCleanOdne AGE-00032024-11-28
06944843655826woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.ES52024-10-17
06944843655833woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.ES5+2024-10-17
06944843655840woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.ES5 Pro2024-10-17
06944843655857woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.ES5 Pro+2024-10-17
06944843655864DTEGuilin Woodpecker Medical Instrument Co., Ltd.ES52024-10-17
06944843655871DTEGuilin Woodpecker Medical Instrument Co., Ltd.ES5+2024-10-17
06944843655888DTEGuilin Woodpecker Medical Instrument Co., Ltd.ES5 Pro2024-10-17
06944843655895DTEGuilin Woodpecker Medical Instrument Co., Ltd.ES5 Pro+2024-10-17
10194665007300A-decA-DEC, INC.343pro2024-07-23
00810021434957DCIDCI International, LLC47502024-05-13
00810021436845DCIDCI International, LLC47522024-05-13
00810021436852DCIDCI International, LLC47512024-05-13
06974416450008Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare2024-03-12
06974416450015Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare.12024-03-12
06974416450022Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare.22024-03-12
06974416450039Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare.32024-03-12
06974416450046Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare.42024-03-12
06974416450053Dental unitFOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.Mare.52024-03-12
D104SAF4302Dentacenter Operative Dental UnitSafari Dentaire IncSAF-430-22023-10-05
D104SAF430Dentacenter Operative Dental UnitSafari Dentaire IncSAF-4302023-10-02
D104SAF4302XP0Dentacenter Operative Dental UnitSafari Dentaire IncSAF-430-2XP2023-10-02
D104SAF4303Dentacenter Operative Dental UnitSafari Dentaire IncSAF-430-22023-10-02
D104SAF433XP0Dentacenter Operative Dental UnitSafari Dentaire IncSAF-430-2XP2023-10-02
D104SAF470Dentacenter Operative Dental UnitSafari Dentaire IncSAF-4702023-10-02
D104SAF500CART0Dentacenter Operative Dental UnitSafari Dentaire IncSAF-500-CART2023-10-02
D104SAF500M2Dentacenter Operative Dental UnitSafari Dentaire IncSAF-500-M22023-10-02
D104SAF500M4Dentacenter Operative Dental UnitSafari Dentaire IncSAF-500-M42023-10-02
D104SAF531SERIES2Dentacenter Operative Dental UnitSafari Dentaire IncSAF-531-Series II2023-10-02
D104SAF60626Dentacenter Operative Dental UnitSafari Dentaire IncSAF-606-2.62023-10-02
D104SAF60646Dentacenter Operative Dental UnitSafari Dentaire IncSAF-606-4.62023-10-02
J021303440001APP-HC-03-XX-00 (Head Controller)W & H Dentalwerk Bürmoos GmbH303440002023-07-19
J021303470001IFB-DC-CO.CO-HS-00 (Interface Board)W & H Dentalwerk Bürmoos GmbH303470002023-07-19
J021303480001RFB-03-0200-00 (Rectifier-Board)W & H Dentalwerk Bürmoos GmbH303480002023-07-19