Device History Record

Document No: Revision: 3.0 Issue# 03 Effective Date: 01-01-2022 Page: 1 of 5

CPO-DHR-001

Case Number:

Product Name:

Manufactured Quantity:

Upper Aligners:

Lower Aligners:

Retainers:

Shipped Quantity:

Process Details: Quality Checks:

The manufacturing process is divided into: All quality parameters are verified according to the requirements mentioned
in QA.WA-002
Input: Impression/scans:
Receive request from the doctor: __________________________________ 1. Impression/scans should not be dragged: PASS
Case type physical impression: _____________________________________ 2. Cervical margin should be cleared: PASS

Review file and complete record: ___________________________________ 3. No holes in the scans or tray show through the material: PASS

4. All teeth should be captured completely in impression/scans: PASS

Digital Treatment Planning:
5. No bubble or extra material elevation should be present in scans as well as
Setup: ________________________________________________________________ impressions: PASS

Jan 11, 2023

Editing and sculpting: _______________________________________________
Remarks:
Stepping: ____________________________________________________________
____________________________________________________________________________________

Upload for visualization: __________________________________________ ____________________________________________________________________________________

____________________________________________________________________________________
Doctor's approval: _________________________________________________
____________________________________________________________________________________
3D printing: _________________________________________________________
____________________________________________________________________________________

Fabrication: ________________________________________________________
Quality checked by:
Finishing, Packaging & Shipment:
Name: ________________________
Laser marking: ______________________________________________________

Finishing: _______________________________________________
Designation: ____________________
Disinfection & Packaging: ________________________________________
Signature: _______________________
Shipping: ___________________________________________________________
 Device History Record

Document No: Revision: 3.0 Issue# 03 Effective Date: 01-01-2022 Page: 2 of 5

CPO-DHR-001

Case Number:

Product Name:

Digital Planning:

Setup:

1. Verify case # and data and photographs etc: PASS

2. Rx followed or not: PASS

3. Special instructions followed or not: PASS

4. If Rx deviated then comments given or not: PASS

5. Basic relationship etc Midline, canine and molar relationship achieved or maintained as per Rx: PASS

6. Proper tipping/torque required for moving teeth: PASS

7. Extraction of teeth need to be verified if required: PASS

8. IPR form filled properly if required: PASS

9. Vertical movement need to be checked within limit of (1mm intrusion and 0.5mm extrusion) and more than that If doctor insists: PASS

10. 90 degree rotated teeth need not to correct: PASS

11. Mesial/distal Translatory movement of molars are not done in presence of third molar: PASS

12. Mesial/Distal Translatory movement of molars more than 2mm are not done: PASS

13. Arch Reconstruction frame should be properly seated on camera stand: PASS

14. Canvas of Initial and final images should not be moved when images are compared: PASS

Remarks: Quality checked by:

Name: __________________________

Designation: ____________________

Signature: _______________________

Stepping:

1. Movements done in the setup are divided into stages: PASS

2. Same number of teeth are moved as provided in the setup: PASS

3. IPR is performed as contacts between teeth become established according to the filled IPR form: PASS

4. Presence or absence of extraction is again verified: PASS

5. Movements are uniformly distributed in different stages for generating models for aligner fabrication: PASS

6. At this point if any further communication or concern has to be communicated with the Doctor is also communicated: PASS

Remarks: Quality checked by:

Name: __________________________

Designation: ____________________

Signature: _______________________
 Device History Record

Document No: Revision: 3.0 Issue# 03 Effective Date: 01-01-2022 Page: 3 of 5

CPO-DHR-001

Case Number:

Product Name:

Digital Planning:

Editing:

1. Canvas of Initial and final images should not be moved when images are compared: PASS

2. Spaces are maintained if present at initial and final: PASS

3. Same number of teeth should be moved which are moving in setup: PASS

4. Teeth anatomy should not be changed: PASS

5. Remove extra noises from images: PASS

6. Gingiva should be made properly, no cervical line and crown should be covered: PASS

7. Gingiva should not cross the inter-dental contact: PASS

Remarks: Quality checked by:

Name: _________________________________

Designation: ___________________________

Signature: _______________________

Animation:

1. The movement that is divided into stages is further arranged in the form of a video: PASS

2. The video provides a summary of stages and provides visual details like IPR, attachments, extraction and requirement for elastics based on the Rx received from the
Doctor: PASS

Remarks: Quality checked by:

Name: _________________________________

Designation: __________________________

Signature: _______________________

Uploading:

1. Data verification: PASS

2.Number of images are complete: PASS

3. IPR form if required: PASS

Quality checked by:
4. Comments if required: PASS

Remarks: Name: __________________________

Designation: ____________________

Signature: _______________________
 Device History Record

Document No: Revision: 3.0 Issue# 03 Effective Date: 01-01-2022 Page: 4 of 5

CPO-DHR-001

Case Number:

Product Name:

3D Printing:

1. After the doctor approves the case, the models for each stage are exported for 3D printing: PASS
2. Resin models are printed through 3D printing machines: PASS
3. Models are printed based of each aligner stage with movement corresponding to that performed in stepping: PASS
4. Each printed model has a case number and aligner tray number mentioned on it for the ease of fabrication and laser marking later on: PASS
5. Printed models are evaluated and sent further for fabrication of aligners: PASS
Remarks: Quality checked by:

Name: ______________________

Designation: ________________

Signature: _______________________

Fabrication:

1. Verify case data: PASS

2. Check series of aligners (aligners belong to same case) and count number of aligners (all fabricated aligners are present): PASS
3. Feed right information like aligner # and patient name in computer: PASS
4. Laser mark: PASS

5. Compare marked aligner with previously marked aligner, there should not be significant difference between them, if found then verify it before
moving ahead: PASS
Remarks: Quality checked by:

Name: _________________________________

Designation: ___________________________

Signature: _______________________

Finishing:

1. Aligner should not be trimmed over cervical line: PASS

2. Inter-dental area should be trimmed in round shape and don’t much trim toward occlusal side: PASS
3. Extra material should be trimmed from aligner which is below cervical line: PASS
4. There should be no flakes on aligner edges: PASS
5. Make C-shape on distal side of last molars if required: PASS

Remarks: Quality checked by:

Name: _______________________________________

Designation: ________________________________

Signature: _______________________
 Device History Record

Document No: Revision: 3.0 Issue# 03 Effective Date: 01-01-2022 Page: 5 of 5

CPO-DHR-001

Case Number:

Product Name:

Disinfect & Packaging:

1. Verify case data: PASS

2. Check series of aligners (aligners belong to same case) and count number of aligners (all fabricated aligners are present): PASS

3. Feed right information like aligner # and patient name in computer: PASS

4. Laser Mark: PASS

5. Compare marked aligner with previously marked aligner, there should not be significant difference between them, if found then verify it before moving ahead: PASS

Remarks: Quality checked by:

Name: ________________________________________

Designation: __________________________________

Signature: _______________________

Shipping:

1. Confirm Case Data (Patient name, Dr.’s name and aligner # on pouch sticker and aligner etc): PASS

2. Where to send (Verify Destination): PASS

Remarks: Quality checked by:

Name: _______________________________________

Designation: _________________________________

Signature: _______________________