Brand Name | INVISALIGN SYSTEM |
Type of Device | ALIGNER, SEQUENTIAL |
Manufacturer (Section D) |
ALIGN TECHNOLOGY, INC. |
2820 orchard parkway |
san jose, ca |
|
Manufacturer Contact |
ryan
hoffmeister
|
2820 orchard parkway |
san jose, ca
|
7891588
|
|
MDR Report Key | 10204106 |
MDR Text Key | 199081932 |
Report Number | 2953749-2020-01721 |
Device Sequence Number | 1 |
Product Code |
NXC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181739 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
06/26/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/26/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | INVISALIGN SYSTEM - COMPREHENSIVE |
Device Catalogue Number | 8812 |
Device Lot Number | 34218884 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/29/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/11/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 32 YR |
|
|