FDA.reportPublic FDA data

Intraoral optical scanning system

Definition
An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.
GUDID devices
240
Last updated
2026-10-04 01:14:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
E27668907712Single use sleeve Primescan BoxSIRONA Dental Systems GmbH68907712026-09-22
00860016329201OriOri IncOri 3 Pediatric Tip2026-08-21
06975456120005UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.UP6102026-08-19
00693856000340DEXIS Imprevo SLIM TIPDental Imaging Technologies CorporationDEXIS Imprevo2026-08-07
08800019601081LS-100-TIPHuvitz Co., Ltd.LS-100-TIP-3S2026-07-17
08800019601128LSO-100-TIPHuvitz Co., Ltd.LSO-100-TIP-NORMAL2026-07-17
08800019601135LSO-100-TIPHuvitz Co., Ltd.LSO-100-TIP-SMALL2026-07-17
00816063022312iTero Lumina Pro DOAAlign Technology, Inc.2219592026-06-25
00693856000142Assembly-IS 3600 SIDE TIPDental Imaging Technologies CorporationIS 36002025-12-04
00693856000166Assembly-IS 3600 POSTERIOR TIPDental Imaging Technologies CorporationIS 36002025-12-04
00693856000180Assembly-IS 3700 NORMAL TIPDental Imaging Technologies CorporationIS 37002025-12-04
00693856000241Assembly-IS 3800 NORMAL TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000265Assembly-IS 3800 SIDE TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000289Assembly-IS 3800 POSTERIOR TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000333Assembly-DEXIS Imprevo TipDental Imaging Technologies CorporationDEXIS Imprevo2025-12-04
05902729752879TRIOS® 43shape Trios A/STST-012019-02-13
05902729753524TRIOS Patient Monitoring3shape Trios A/SR1.52021-05-28
05902729753661TRIOS3shape Trios A/STB-042022-09-26
05902729753753TRIOS3shape Trios A/STST-112022-09-26
05902729754033TRIOS Dx3shape Trios A/SR1.y2026-04-23
05902729754040TRIOS Dx3shape Trios A/SR1.02026-04-23
05902729754187TRIOS Dx3shape Trios A/SR1.12026-04-23
06973993440037AlliedStarAlliedstar Medical Equipment Co., Ltd.AS 200E2022-12-11
06973993440884Dandy VisionAlliedstar Medical Equipment Co., Ltd.DI-12025-10-24
06973993441034AlliedStarAlliedstar Medical Equipment Co., Ltd.TP2022022-12-11
06973993441041AlliedStarAlliedstar Medical Equipment Co., Ltd.TP2032022-12-11
06973993441065NeoScanAlliedstar Medical Equipment Co., Ltd.TP103N2022-09-20
06973993441386AlliedstarAlliedstar Medical Equipment Co., Ltd.TP2042025-10-17
06973993441720Straumann SIRIOS X3Alliedstar Medical Equipment Co., Ltd.TP3112025-08-15
06973993441904Dandy VisionAlliedstar Medical Equipment Co., Ltd.N/A2025-10-24
06973993441942Dandy VisionAlliedstar Medical Equipment Co., Ltd.TPDI1L2025-10-27
06973993441959Dandy VisionAlliedstar Medical Equipment Co., Ltd.TPDI1S2025-10-27
06973993442024AlliedStarAlliedstar Medical Equipment Co., Ltd.AS 200E2022-12-11
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.ST 200E2026-04-20
06973993442864Dandy VisionAlliedstar Medical Equipment Co., Ltd.DI-12025-10-24
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.UP6102026-05-18
08800025400135InspireGOOD DOCTORS CO., LTD.IC-WHCD1002020-11-13
08800026700876i900 Series Single Use TipMedit Corp.MO1-ST12026-02-03
DIVO7402781VivaScanIVOCLAR VIVADENT AKTIENGESELLSCHAFT7402782022-03-15
DIVO7544721Ceramill map DRSIVOCLAR VIVADENT AKTIENGESELLSCHAFT7544722022-03-15
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbH68053652025-09-16
E27668082030Primescan 2SIRONA Dental Systems GmbH68082032025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbH68082452025-10-23
E27668186992Primescan 2SIRONA Dental Systems GmbH68186992024-03-14
E27668558402Primescan 2SIRONA Dental Systems GmbH68558402025-08-20
18800026700873i900 Series Single Use TipMedit Corp.MO1-ST12026-02-03
00860008859556OriOri IncOri 3 Tip2026-01-23
06970569090993iRayiRay GroupiScan2026-01-13
06973993440785AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 200E2025-12-11
06973993440808AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 2602025-12-11
06973993441119AlliedstarAlliedstar Medical Equipment Co., Ltd.Li-18650-3.6V 3400mAh-PCM-Cap2025-12-11
06973993441522AlliedstarAlliedstar Medical Equipment Co., Ltd./2025-12-11
06973993441539AlliedstarAlliedstar Medical Equipment Co., Ltd./2025-12-11
06973993441546AlliedstarAlliedstar Medical Equipment Co., Ltd./2025-12-11
06973993441775AlliedstarAlliedstar Medical Equipment Co., Ltd.CHR 200E2025-12-11
06973993442307AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 200E2025-12-11
06973993442314AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 200E2025-12-11
06973993442765AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 200E2025-12-11
06973993442796AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 2602025-12-11
06973993442819AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 2602025-12-11
06973993442826AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 2602025-12-11
06973993442833AlliedstarAlliedstar Medical Equipment Co., Ltd.AS 2602025-12-11
16973993441116AlliedstarAlliedstar Medical Equipment Co., Ltd.Li-18650-3.6V 3400mAh-PCM-Cap2025-12-11
00860008859549OriOri IncOri 3 System2025-12-09
00860008859563OriOri IncOri 3 Scanner2025-12-09
00693856000159Assembly-IS 3600 SIDE TIPDental Imaging Technologies CorporationIS 36002025-12-04
00693856000173Assembly-IS 3600 POSTERIOR TIPDental Imaging Technologies CorporationIS 36002025-12-04
00693856000197Assembly-IS 3700 NORMAL TIPDental Imaging Technologies CorporationIS 37002025-12-04
00693856000203Assembly-IS 3700 SIDE TIPDental Imaging Technologies CorporationIS 37002025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPDental Imaging Technologies CorporationIS 37002025-12-04
00693856000258Assembly-IS 3800 NORMAL TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000272Assembly-IS 3800 SIDE TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000296Assembly-IS 3800 POSTERIOR TIPDental Imaging Technologies CorporationIS 38002025-12-04
00693856000326Assembly-DEXIS Imprevo TipDental Imaging Technologies CorporationDEXIS Imprevo2025-12-04
00693856000128Assembly-IS 3600 NORMAL TIPDental Imaging Technologies CorporationIS 36002025-12-03
08800293009726R2i5Megagen Implant Co. Ltd3DS Mega2025-12-03
06974566270129FUSSENFussen Technology Co., Ltd.S102025-11-20
08800019601005LilivisHuvitz Co., Ltd.LS-100-TIP-3R2025-09-08
06977274260253Intraoral ScannerChangsha Honchon Technology Co., LTDHCE-IS-1302025-08-31
06977274260260Intraoral ScannerChangsha Honchon Technology Co., LTDHCE-IS-3002025-08-31