FDA.reportPublic FDA data

Dental delivery system instrument unit, pneumatic

Definition
A pneumatically-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
381
Last updated
2026-10-13 01:08:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850043433002Cabinet Top Mount Rear DeliveryEngle Dental Systems, LLCP0714382022-12-07
00850043433019Cabinet Side Mount Rear DeliveryEngle Dental Systems, LLCP0714502022-12-09
00850043433026Cabinet Asst Only Rear DeliveryEngle Dental Systems, LLCP0714602022-12-09
00850043433033AS1 Dr./Asst Rear DeliveryEngle Dental Systems, LLCP0709002022-12-09
00850043433040AS1 Wall Mnt Rear DeliveryEngle Dental Systems, LLCP0709022022-12-09
00850043433057Assistant Wall Mount ArmEngle Dental Systems, LLCP0709042022-12-09
00850043433064Rear DeliveryEngle Dental Systems, LLCP0719642022-12-09
00850043433071Silver Mobile CartEngle Dental Systems, LLCP0503002022-12-09
00850043433088Gold Mobile CartEngle Dental Systems, LLCP0503102022-12-09
00850043433095Platinum Mobile CartEngle Dental Systems, LLCP0503202022-12-09
00850043433101Asst Platinum CartEngle Dental Systems, LLCP0503302022-12-09
00850043433118Asst Silver CartEngle Dental Systems, LLCP0503402022-12-09
00850043433125Dr./Asst Tabletop CartEngle Dental Systems, LLCP0501352022-12-09
00850043433132Asst Tabletop CartEngle Dental Systems, LLCP0501452022-12-09
00850043433149Dr. Flip Top CartEngle Dental Systems, LLCP0501402022-12-09
00850043433156Hygiene Flip Top CartEngle Dental Systems, LLCP0501502022-12-09
00850043433231E300 360 Delivery SystemEngle Dental Systems, LLCP0709312022-12-09
00850043433248AS1 360 Delivery SystemEngle Dental Systems, LLCP0709282022-12-09
00850043433255E300 Hygiene Delivery SystemEngle Dental Systems, LLCP0709372022-12-09
00850043433262E320 OTP Delivery SystemEngle Dental Systems, LLCP0709252022-12-09
00850043433279E310 OTP Cuspidor Delivery SystemEngle Dental Systems, LLCP0709202022-12-09
00850043433286E200 AS1 Delivery SystemEngle Dental Systems, LLCP0709122022-12-09
00850043433293E1200 AS1 Delivery SystemEngle Dental Systems, LLCP0708672022-12-09
00850043433309E2200 Delivery SystemEngle Dental Systems, LLCP0708732022-12-09
00850043433316E120 Hygiene Delivery SystemEngle Dental Systems, LLCP0708852022-12-09
00850043433323E220 Hygiene Delivery SystemEngle Dental Systems, LLCP0708862022-12-09
00850043433330E300 Post Delivery SystemEngle Dental Systems, LLCP0709352022-12-09
00850043433347E300 Wall Delivery SystemEngle Dental Systems, LLCP0709362022-12-09
00850043433354E300 Wall Short Arm Delivery SystemEngle Dental Systems, LLCP070936S2022-12-09
00850043433361AS-1 Post Delivery SystemEngle Dental Systems, LLCP0708752022-12-09
00850043433378AS-1 Wall Delivery SystemEngle Dental Systems, LLCP0708762022-12-09
00850043433385AS-1 Wall Short Arm Delivery SystemEngle Dental Systems, LLCP070876S2022-12-09
00850043433392Panel Mount Delivery HeadEngle Dental Systems, LLCP0293552022-12-09
00850043433408360 Asst ArmEngle Dental Systems, LLCP0222752022-12-09
00850043433415Asst Arm - Top MountEngle Dental Systems, LLC22-502-022022-12-09
00850043433422Asst Arm - ShortEngle Dental Systems, LLC22-507-012022-12-09
00850043433439Asst Arm - LongEngle Dental Systems, LLC22-507-022022-12-09
00850043433446Asst Vac KitEngle Dental Systems, LLCP0225012022-12-09
00850043433453360 Cuspidor ArmEngle Dental Systems, LLCP0692652022-12-09
00850043433460Utility Center w/ArmEngle Dental Systems, LLCP0692012022-12-09
00850043433477Utility Center w/CuspidorEngle Dental Systems, LLCP0692402022-12-09
00850043433484E2 360 Delivery SystemEngle Dental Systems, LLCP0709412023-12-14
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCP0714702024-11-06
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCP0709052025-08-26
00850043433521E300 Delivery SystemEngle Dental Systems, LLCP0709162026-02-09
00810063750534Safco Incite Slow Speed Handpiece SetSAFCO DENTAL SUPPLY CO.10228832022-12-12
00810063750541Safco Incite Slow Speed Handpiece SetSAFCO DENTAL SUPPLY CO.10228852022-12-12
00810021439532DCI EdgeDCI International, LLC42856G2026-03-23
00810021439549DCI EdgeDCI International, LLC42856W2026-03-23
00810021439556DCI EdgeDCI International, LLC42857G2026-03-23
00810021439563DCI EdgeDCI International, LLC42857W2026-03-23
00810021439570DCI EdgeDCI International, LLC52893G2026-03-23
00810021439587DCI EdgeDCI International, LLC52893W2026-03-23
00810021439594DCI EdgeDCI International, LLC52906G2026-03-23
00810021439600DCI EdgeDCI International, LLC52906W2026-03-23
00810021439617DCI EdgeDCI International, LLCDO57562026-03-23
00810021439518DCI PartsDCI International, LLC4404L2026-03-20
00810021439525DCI PartsDCI International, LLC4404R2026-03-20
00810021436791DCI EdgeDCI International, LLC420432025-12-15
D178A12HP1000Flight Dental SystemsFlight Dental Systems USA Inc.A12H-1002025-08-29
D178A6EP1000Flight Dental SystemsFlight Dental Systems USA Inc.A6EP-1002025-08-29
D178A6EP10120Flight Dental SystemsFlight Dental Systems USA Inc.A6EP-1022025-08-29
00810021436876DCI EdgeDCI International, LLCDS5051+2025-02-24
00810021436883DCI EdgeDCI International, LLCDS5550+2025-02-24
00810021436937DCI EdgeDCI International, LLCDS5551+2025-02-24
00810021436944DCI EdgeDCI International, LLCDO5650+2025-02-24
00810021437019DCI EdgeDCI International, LLCDO5550+2025-02-24
00810021437026DCI EdgeDCI International, LLCDO5050+2025-02-24
00810021437033DCI EdgeDCI International, LLCDO5150+2025-02-24
00810021437040DCI EdgeDCI International, LLCDO5554+2025-02-24
00810021437057DCI EdgeDCI International, LLCDO5654+2025-02-24
00810021437064DCI EdgeDCI International, LLCDO5754+2025-02-24
00810021437156DCI EdgeDCI International, LLCDO5756+2025-02-24
00810021437163DCI EdgeDCI International, LLCDO5854+2025-02-24
00810021437781DCI EdgeDCI International, LLCDW5050+2025-02-24
D1351480DOME Coronado Dental Delivery UnitDome, Inc.1482025-01-15
00810021430966DCIDCI International, LLCBDU-5002024-08-02
00810021430973DCIDCI International, LLCBDU-5102024-08-02
00810021430980DCIDCI International, LLCBDU-5702024-08-02
00810021430997DCIDCI International, LLCBDU-5752024-08-02