Device Classification Name |
caries detector, laser light, transmission
|
510(k) Number |
K193659 |
Device Name |
iTero Element 5D |
Applicant |
Align Technology, Inc. |
2820 Orchard Parkway |
San Jose,
CA
95134
|
|
Applicant Contact |
Angela M. Frederickson |
Correspondent |
Hogan Lovells US LLP |
1601 Wewatta St #900 |
Denver,
CO
80202
|
|
Correspondent Contact |
Angela Frederickson |
Regulation Number | 872.1745
|
Classification Product Code |
|
Date Received | 12/30/2019 |
Decision Date | 03/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|