| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | E2768752250 | 875225 | Midwest® Endo 6:1 | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest® Endo | |
| 2 | E2767924300 | 792430 | Midwest Stylus® Plus SPK | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 3 | E2767924200 | 792420 | Midwest Stylus® Plus SPN | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 4 | E2767924100 | 792410 | Midwest Stylus® Plus SPS | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 5 | E2767924000 | 792400 | Midwest Stylus® Plus SPM | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 6 | E2767923310 | 792331 | Midwest Stylus® Plus SPK-SH | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 7 | E2767923010 | 792301 | Midwest Stylus® Plus SPM-SH | EFB | Handpiece, Air-Powered, Dental | 1 | Midwest Stylus® Plus | |
| 8 | E2767904360 | 790436 | 6-Pin LED Coupler, S-Style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 9 | E2767904350 | 790435 | 5-Hole Coupler, S-Style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 10 | E2767903380 | 790338 | 4-Hole Coupler, S-Style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 11 | E2767903351 | 790335 | 5-Hole Coupler, K-style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 12 | E2767902460 | 790246 | 6-Pin Coupler, MW style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 13 | E2767902450 | 790245 | 5-Hole Coupler, MW style | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling | |
| 14 | E2767600210 | 720021 | Rhino XE U-Style Adapter 7:1 E-Type | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 15 | E2767600200 | 760020 | Midwest® U-style Adapter | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 16 | E2767200300 | 720030 | E-Type K-Style Straight Attachment | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 17 | E2767200060 | 720006 | Rhino XE Straight Attachment E-Type | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 18 | E2767104850 | 710485 | Rhino XE CA 1:1 PB Latch Chuck E-Type | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 19 | E2767104300 | 710430 | E-Type K-Style CA 1:1 Latch Chuck | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 20 | E2767100780 | 710078 | Midwest® Right Angle Sheath | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 21 | E2767100740 | 710074 | Midwest® Contra Angle Sheath | EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | Midwest Low Speed Attachment | |
| 22 | E2766669589 | 6669589 | 6669589 | Guide Sleeve Astra Tech EV ND | NDP | Accessories, Implant, Dental, Endosseous | CEREC Guide 3 | |
| 23 | E2766669571 | 6669571 | 6669571 | Guide Sleeve Ankylos WDGuide Sleeve Ankylos ND / XiVe ND | NDP | Accessories, Implant, Dental, Endosseous | CEREC Guide 3 | |
| 24 | E27666695632 | 6669563 | 6669563 | Guide Sleeve Ankylos ND / XiVe NDGuide Sleeve Ankylos ND / XiVe ND | NDP | Accessories, Implant, Dental, Endosseous | CEREC Guide 3 | |
| 25 | E27666322640 | 6632264 | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | Disposable Sleeve Omnicam (50 pcs.) | ||
| 26 | E2766593359 | 6593359 | Retrofit kit | OAS | X-Ray, Tomography, Computed, Dental | 2 | 3D-Modul 8x8 für OP SL/S 2D | |
| 27 | E27665587090 | 6558709 | Treatment Center INTEGO TS | EIA,EBW | Unit, Operative Dental,Controller, Foot, Handpiece And Cord | 1 | INTEGO TS | |
| 28 | E27665512742 | 6551274 | inCoris CCB disc 20 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 29 | E27665512662 | 6551266 | inCoris CCB disc 18 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 30 | E27665512582 | 6551258 | inCoris CCB disc 16 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 31 | E27665512412 | 6551241 | inCoris CCB disc 14 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 32 | E27665512332 | 6551233 | inCoris CCB disc 12 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 33 | E27665512252 | 6551225 | inCoris CCB disc 10 | EJH | Alloy, Metal, Base | 2 | inCoris CCB | |
| 34 | E27664836920 | 6483692 | HD PLUS complete w/o support arm | EHD | Unit, X-Ray, Extraoral With Timer | 2 | HELIODENT Plus | |
| 35 | E27664734380 | 6473438 | Ceph SL arm right cpl. | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 36 | E27664731230 | 6473123 | Ceph SL arm left cpl. | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 37 | E27664664400 | 6466440 | OP SL 3D individ. | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 38 | E27664649990 | 6464999 | OP SL 3D 11x10 DCS | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 39 | E27664649810 | 6464981 | OP SL 3D 11x10 | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 40 | E27664649730 | 6464973 | OP SL 3D 8x8 DCS | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 41 | E27664649650 | 6464965 | OP SL 3D 8x8 | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 42 | E27664649570 | 6464957 | OP SL 2D | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 43 | E27664403950 | 6440395 | OP SL 2D individ. | OAS | X-Ray, Tomography, Computed, Dental | 2 | ORTHOPHOS SL | |
| 44 | E27663870180 | 6387018 | T1 mini N | EFB | Handpiece, Air-Powered, Dental | 1 | T1 mini | |
| 45 | E27663870000 | 6387000 | T1 mini W | EFB | Handpiece, Air-Powered, Dental | 1 | T1 mini | |
| 46 | E27663869940 | 6386994 | T1 mini K | EFB | Handpiece, Air-Powered, Dental | 1 | T1 mini | |
| 47 | E27663866300 | 6386630 | T1 mini S | EFB | Handpiece, Air-Powered, Dental | 1 | T1 mini | |
| 48 | E27663324020 | 6332402 | HD Plus ceilling complete | EHD | Unit, X-Ray, Extraoral With Timer | 2 | HELIODENT Plus | |
| 49 | E27663246490 | 6324649 | Extraoral Scanner | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | InEos X5 | |
| 50 | E27663197060 | 6319706 | Quick coupling R | EFB | Handpiece, Air-Powered, Dental | 1 | Quick coupling |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05902768365283 | 2015-1 | 3Shape’s Ortho System™ is a software system used for the management of 3D scanne 3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials. | 3Shape Ortho System | 3SHAPE A/S | |
| 2 | 05902729753654 | R1.0 | DentalSystem-backed web service for automatic designs of crowns. | Automate | 3SHAPE TRIOS A/S | |
| 3 | 05902729753555 | R1.0 | Dental treatment application software | Splint Design | 3SHAPE A/S | |
| 4 | 05902729753487 | 85.x | CAD/CAM software | Ortho System | 3SHAPE A/S | |
| 5 | 05902729752954 | 1.1.x | Dental treatment application software | Splint Design | 3SHAPE A/S | |
| 6 | 05902729752787 | 2018-1 | CAD/CAM software | Ortho System | 3SHAPE A/S | |
| 7 | 05902729752510 | 2017-1 | CAD/CAM software | Ortho System | 3SHAPE A/S | |
| 8 | E27667844950 | 6784495 | CEREC Ortho Software Version 2.1 Upgrade | CEREC Ortho Software | SIRONA DENTAL SYSTEMS GMBH | |
| 9 | E27667483590 | 6748359 | CEREC Ortho Software Version 2.1 | CEREC Ortho Software | SIRONA DENTAL SYSTEMS GMBH | |
| 10 | E27666979860 | 6697986 | CEREC Ortho Software Version 2.0.0 | CEREC Ortho Software | SIRONA DENTAL SYSTEMS GMBH | |
| 11 | E27666111690 | 6611169 | CEREC Ortho Software Version 1.2.0 | CEREC Ortho Software | SIRONA DENTAL SYSTEMS GMBH | |
| 12 | 00860461001707 | Version 2.2 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 13 | 00860008123404 | 1 | Orthodontic Software | Orchestrate 3D | ORCHESTRATE 3D | |
| 14 | 00860002380087 | 7 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. | uLab Systems uDesign | ULAB SYSTEMS, INC. | |
| 15 | 00860002380070 | 6.0 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. | uLab Systems uDesign | ULAB SYSTEMS, INC. | |
| 16 | 00860002380049 | 5.9 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 17 | 00860002380032 | Version 5.8 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 18 | 00860002380025 | Version 5.6 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 19 | 00860002380018 | Version 5.5 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 20 | 00860002380001 | Version 5 | FG0064 | The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers | uLab Systems uDesign | ULAB SYSTEMS, INC. |
| 21 | 00850018135139 | Lower Patient Kit | 8121 | Inbrace Teeth Straightening System | SWIFT HEALTH SYSTEMS INC. | |
| 22 | 00850018135122 | Digital Engancement | 8131 | Inbrace Teeth Straightening System | SWIFT HEALTH SYSTEMS INC. | |
| 23 | 00850018135054 | Lower Fitting Kit | 85003 | InBrace Teeth Straightening System (Gen 2.0) | SWIFT HEALTH SYSTEMS INC. | |
| 24 | 00850018135047 | Fitting Kit | 85000 | InBrace Teeth Straightening System (Gen 2.0) | SWIFT HEALTH SYSTEMS INC. | |
| 25 | 00850018135030 | Upper Fitting Kit | 85002 | InBrace Teeth Straightening System (Gen 2.0) | SWIFT HEALTH SYSTEMS INC. | |
| 26 | 00850018135016 | Upper Patient Kit | 8111 | Inbrace Teeth Straightening System | SWIFT HEALTH SYSTEMS INC. | |
| 27 | 00850018135009 | Standard Patient Kit | 8101 | Inbrace Teeth Straightening System | SWIFT HEALTH SYSTEMS INC. | |
| 28 | 60192155944482 | 5944483 | 5944483 | LICENCE CS MODEL+ V5 ALIGNER CAPABILITY | CS Model+ | CARESTREAM DENTAL LLC |
| 29 | 60192155942716 | CS Model+ | 5942719 | CS MODEL+ | CS Model+ | CARESTREAM DENTAL LLC |