No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00860002380094 | FG0094 | The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that con The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position. | NXC | Aligner, Sequential | 2 | uLab Systems Dental Aligner | |
2 | 00860002380063 | FG0094 Rev. D | NXC | Aligner, Sequential | 2 | uLab Systems Dental Aligner | ||
3 | 00860002380056 | FG0094 | NXC | Aligner, Sequential | 2 | uLab Systems Dental Aligner | ||
4 | 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 | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign |
5 | 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. | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign | |
6 | 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. | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign | |
7 | 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. | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign |
8 | 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. | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign |
9 | 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. | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign |
10 | 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 | LLZ,PNN | System, Image Processing, Radiological,Orthodontic Software | 2 | uLab Systems uDesign |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00815131026726 | BSP | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | ||
2 | 00815131026412 | Blue Sky Plan Software | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | ||
3 | 00811852030288 | Viz CTP Software | Viz CTP v1.9 (2022-09-04) | Viz CTP | VIZ.AI, INC. | |
4 | 00811852030141 | 1.4 | Viz CTP 1.4 | Viz CTP | VIZ.AI, INC. | |
5 | 00811852030103 | 1.3 | Viz CTP 1.3 | Viz CTP | VIZ.AI, INC. | |
6 | 00811852030066 | 1.2 | Viz CTP 1.2 | Viz CTP | VIZ.AI, INC. | |
7 | 00811852030011 | 1.1 | Viz CTP 1.1 | Viz CTP | VIZ.AI, INC. | |
8 | 00810035220379 | 5 | A software application to facilitate management, distribution, and/or viewing of A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation. | Radmedix AccuVue+ | RADMEDIX, LLC | |
9 | 00810007631103 | ZB-3D208 | ZB-3D208 | ANATOMICAL MODEL, RIB, SINGLE | AccuModel® | MEDCAD |
10 | 00810007631073 | ACS_GU | ACS_GU | ANATOMICAL MODEL, GUIDE | AccuModel | MEDCAD |
11 | 00810007630861 | ZB-3D108 | ZB-3D108 | ANATOMICAL MODEL, FIBULA | AccuModel® | MEDCAD |
12 | 00810007630854 | ZB-3D207 | ZB-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel® | MEDCAD |
13 | 00810007630847 | ZB-3D206 | ZB-3D206 | ANATOMICAL MODEL, SKULL | AccuModel® | MEDCAD |
14 | 00810007630830 | ZB-3D204 | ZB-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel® | MEDCAD |
15 | 00810007630823 | ZB-3D203 | ZB-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel® | MEDCAD |
16 | 00810007630816 | ZB-3D202 | ZB-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel® | MEDCAD |
17 | 00810007630809 | ZB-3D102 | ZB-3D102 | ANATOMICAL MODEL, GRAFT | AccuModel® | MEDCAD |
18 | 00810007630793 | ZB-3D101 | ZB-3D101 | ANATOMICAL MODEL, IMPLANT MODEL | AccuModel® | MEDCAD |
19 | 00810007630786 | ZB-3D100 | ZB-3D100 | ANATOMICAL MODEL, HOST BONE PERI-DEFECT | AccuModel® | MEDCAD |
20 | 00810007630779 | ZB-3D-M | ZB-3D-M | ANATOMICAL MODEL, MISCELLANEOUS | AccuModel® | MEDCAD |
21 | 00810007630762 | ZB-K030 | ZB-K030 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN | AccuPlan® System | MEDCAD |
22 | 00810007630755 | ZB-K021 | ZB-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
23 | 00810007630748 | ZB-K020-R | ZB-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
24 | 00810007630731 | ZB-K020 | ZB-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
25 | 00810007630724 | ZB-K011 | ZB-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
26 | 00810007630717 | ZB-K010-R | ZB-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
27 | 00810007630700 | ZB-K010 | ZB-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
28 | 00810007630694 | ZB-K004 | ZB-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
29 | 00810007630687 | ZB-K003 | ZB-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan® System | MEDCAD |
30 | 00810007630670 | ZB-K002 | ZB-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan® System | MEDCAD |
31 | 00810007630663 | ZB-K001 | ZB-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan® System | MEDCAD |
32 | 00810007630656 | ZB-K000-R | ZB-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
33 | 00810007630649 | ZB-K000 | ZB-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
34 | 00810007630533 | MC-K000-R | MC-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
35 | 00810007630441 | MC-K020-R | MC-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
36 | 00810007630427 | MC-K020 | MC-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
37 | 00810007630373 | MC-K021 | MC-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
38 | 00810007630366 | MC-K011 | MC-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
39 | 00810007630359 | MC-K010-R | MC-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
40 | 00810007630342 | MC-K004 | MC-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan System | MEDCAD |
41 | 00810007630335 | MC-K010 | MC-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
42 | 00810007630328 | MC-K003 | MC-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan System | MEDCAD |
43 | 00810007630311 | MC-K002 | MC-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan System | MEDCAD |
44 | 00810007630304 | MC-K001 | MC-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan System | MEDCAD |
45 | 00810007630298 | MC-K000 | MC-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
46 | 00810007630281 | MC-3D207 | MC-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel | MEDCAD |
47 | 00810007630274 | MC-3D206 | MC-3D206 | ANATOMICAL MODEL, SKULL | AccuModel | MEDCAD |
48 | 00810007630267 | MC-3D204 | MC-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel | MEDCAD |
49 | 00810007630250 | MC-3D203 | MC-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel | MEDCAD |
50 | 00810007630243 | MC-3D202 | MC-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel | MEDCAD |