The following data is part of a premarket notification filed by Align Technology, Inc. with the FDA for Itero Element 5d.
| Device ID | K193659 |
| 510k Number | K193659 |
| Device Name: | ITero Element 5D |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | Align Technology, Inc. 2820 Orchard Parkway San Jose, CA 95134 |
| Contact | Angela M. Frederickson |
| Correspondent | Angela Frederickson Hogan Lovells US LLP 1601 Wewatta St #900 Denver, CO 80202 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816063020653 | K193659 | 000 |
| 00816063021001 | K193659 | 000 |
| 00816063020875 | K193659 | 000 |
| 00816063020868 | K193659 | 000 |
| 00816063020813 | K193659 | 000 |
| 00816063020806 | K193659 | 000 |
| 00816063020790 | K193659 | 000 |
| 00816063020783 | K193659 | 000 |
| 00816063020776 | K193659 | 000 |
| 00816063020752 | K193659 | 000 |
| 00816063020745 | K193659 | 000 |
| 00816063020721 | K193659 | 000 |
| 00816063020707 | K193659 | 000 |
| 00816063021018 | K193659 | 000 |
| 00816063021025 | K193659 | 000 |
| 00816063021049 | K193659 | 000 |
| 00816063020646 | K193659 | 000 |
| 00816063020639 | K193659 | 000 |
| 00816063020622 | K193659 | 000 |
| 00816063020615 | K193659 | 000 |
| 00816063020578 | K193659 | 000 |
| 00816063020561 | K193659 | 000 |
| 00816063020509 | K193659 | 000 |
| 00816063020493 | K193659 | 000 |
| 00816063021100 | K193659 | 000 |
| 00816063021094 | K193659 | 000 |
| 00816063021087 | K193659 | 000 |
| 00816063021063 | K193659 | 000 |
| 00816063020691 | K193659 | 000 |