| 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 | 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 | 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 | 00888867345904 | AR-VIPBASE | AR-VIPBASE | VIP 3D BASE | Arthrex® | ARTHREX, INC. |
| 2 | 00888867335769 | AR-VIP3D | AR-VIP3D | VIP GLENOID 3D MODEL | Arthrex® | ARTHREX, INC. |
| 3 | 00888867315525 | AR-5400-25 | AR-5400-25 | SIZE 25 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 4 | 00888867315518 | AR-5400-24 | AR-5400-24 | SIZE 24 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 5 | 00888867315501 | AR-5400-23 | AR-5400-23 | SIZE 23 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 6 | 00888867315495 | AR-5400-22 | AR-5400-22 | SIZE 22 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 7 | 00888867315488 | AR-5400-21 | AR-5400-21 | SIZE 21 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 8 | 00888867315471 | AR-5400-20 | AR-5400-20 | SIZE 20 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 9 | 00888867315464 | AR-5400-19 | AR-5400-19 | SIZE 19 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 10 | 00888867315457 | AR-5400-18 | AR-5400-18 | SIZE 18 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 11 | 00888867315440 | AR-5400-17 | AR-5400-17 | SIZE 17 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 12 | 00888867315433 | AR-5400-16 | AR-5400-16 | SIZE 16 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 13 | 00888867315426 | AR-5400-15 | AR-5400-15 | SIZE 15 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 14 | 00888867315419 | AR-5400-14 | AR-5400-14 | SIZE 14 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 15 | 00888867315402 | AR-5400-13 | AR-5400-13 | SIZE 13 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 16 | 00888867315396 | AR-5400-12 | AR-5400-12 | SIZE 12 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 17 | 00888867315389 | AR-5400-11 | AR-5400-11 | SIZE 11 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 18 | 00888867315372 | AR-5400-10 | AR-5400-10 | SIZE 10 LEG, GLENOID TARGETER | Arthrex® | ARTHREX, INC. |
| 19 | 00888867315365 | AR-5400-04 | AR-5400-04 | GLENOID TARGETER LOCKING NUT | Arthrex® | ARTHREX, INC. |
| 20 | 00888867315358 | AR-5400-03 | AR-5400-03 | GLENOID TARGETER CAPTURE NUT | Arthrex® | ARTHREX, INC. |
| 21 | 00888867315341 | AR-5400-02 | AR-5400-02 | GLENOID TARGETER HANDLE | Arthrex® | ARTHREX, INC. |
| 22 | 00888867315334 | AR-5400-01 | AR-5400-01 | GLENOID TARGETER SHAFT | Arthrex® | ARTHREX, INC. |
| 23 | 00888118136152 | 60-500-25-09 | SPLINT, PALATAL, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
| 24 | 00888118136145 | 60-500-19-09 | SPLINT, INTERMEDIATE, FREEPRINT ORTHO | IPS | KLS-MARTIN L.P. | |
| 25 | 00888118136138 | 60-500-18-09 | SPLINT, FINAL, EGUARD BLUE | IPS | KLS-MARTIN L.P. | |
| 26 | 00888118136121 | 60-500-17-09 | SPLINT, SUPPLEMENTAL, EGUARD BLUE | IPS | KLS-MARTIN L.P. | |
| 27 | 00888118136114 | 60-500-16-09 | SPLINT, SUPPLEMENTAL, FREEPRINT ORTHO | IPS | KLS-MARTIN L.P. | |
| 28 | 00888118136107 | 60-500-15-09 | SPLINT, INTERMEDIATE, EGUARD BLUE | IPS | KLS-MARTIN L.P. | |
| 29 | 00888118136091 | 60-500-14-09 | SPLINT, FINAL, FREEPRINT ORTHO | IPS | KLS-MARTIN L.P. | |
| 30 | 00888118129574 | 60-008-67-09 | CUTTING GUIDE, DISTRACTION | IPS | KLS-MARTIN L.P. | |
| 31 | 00888118129567 | 60-008-63-09 | MARKING GUIDE, DISTRACTION | IPS | KLS-MARTIN L.P. | |
| 32 | 00888118129550 | 60-008-53-09 | CUTTING GUIDE, W/PLANNING, DISTRACTION | IPS | KLS-MARTIN L.P. | |
| 33 | 00888118129543 | 60-008-30-09 | MARKING GUIDE, W/PLANNING, DISTRACTION | IPS | KLS-MARTIN L.P. | |
| 34 | 00888118129536 | 60-004-38-09 | MARKING GUIDE, RECON, COMPLEX | IPS | KLS-MARTIN L.P. | |
| 35 | 00888118129529 | 60-004-37-09 | MARKING GUIDE, ORTHOG, XL | IPS | KLS-MARTIN L.P. | |
| 36 | 00888118129512 | 60-004-36-09 | CUTTING GUIDE, ORTHOG, XL | IPS | KLS-MARTIN L.P. | |
| 37 | 00888118129505 | 60-004-35-09 | CUTTING GUIDE, ORTHOG, BONE BASED | IPS | KLS-MARTIN L.P. | |
| 38 | 00888118129291 | 60-002-88-09 | MARKING GUIDE, TRANSFORM, EXTRA, LARGE | IPS | KLS-MARTIN L.P. | |
| 39 | 00888118129284 | 60-002-87-09 | MARKING GUIDE, TRANSFORM, EXTRA, SMALL | IPS | KLS-MARTIN L.P. | |
| 40 | 00888118129277 | 60-002-86-09 | MARKING GUIDE, W/PLANNING, TRANSFORM | IPS | KLS-MARTIN L.P. | |
| 41 | 00888118129253 | 60-002-84-09 | CUTTING GUIDE, TRANSFORM, EXTRA, LARGE | IPS | KLS-MARTIN L.P. | |
| 42 | 00888118129246 | 60-002-83-09 | CUTTING GUIDE, TRANSFORM, EXTRA, SMALL | IPS | KLS-MARTIN L.P. | |
| 43 | 00888118129239 | 60-002-82-09 | CUTTING GUIDE, W/PLANNING, TRANSFORM | IPS | KLS-MARTIN L.P. | |
| 44 | 00888118128225 | 60-004-13-09 | MARKING GUIDE, THORACIC, PECTUS, EXTRA | IPS | KLS-MARTIN L.P. | |
| 45 | 00888118128218 | 60-004-12-09 | MARKING GUIDE, W/PLANNING, THORACIC, PECTUS | IPS | KLS-MARTIN L.P. | |
| 46 | 00888118128201 | 60-004-11-09 | CUTTING GUIDE, THORACIC, PECTUS, EXTRA | IPS | KLS-MARTIN L.P. | |
| 47 | 00888118128195 | 60-004-10-09 | CUTTING GUIDE, W/PLANNING, THORACIC, PECTUS | IPS | KLS-MARTIN L.P. | |
| 48 | 00888118127976 | 60-004-06-09 | CUTTING GUIDE, THORACIC, LARGE | IPS | KLS-MARTIN L.P. | |
| 49 | 00888118127969 | 60-004-05-09 | MARKING GUIDE, THORACIC, LARGE | IPS | KLS-MARTIN L.P. | |
| 50 | 00888118127952 | 60-004-04-09 | CUTTING GUIDE, THORACIC, SMALL | IPS | KLS-MARTIN L.P. |