The following data is part of a premarket notification filed by Stratasys Ltd with the FDA for Stratasys Truedent.
| Device ID | K220771 |
| 510k Number | K220771 |
| Device Name: | Stratasys TrueDent |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Stratasys Ltd 1 Holtzman St. Science Park P.O. Box 2496 Rehovot, IL 7612401 |
| Contact | Melanie Glennon |
| Correspondent | Melissa Burbage PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | EBI |
| Subsequent Product Code | EBF |
| Subsequent Product Code | EBG |
| Subsequent Product Code | PZY |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018915806 | K220771 | 000 |
| 07290018915608 | K220771 | 000 |
| 07290018915400 | K220771 | 000 |
| 07290018915202 | K220771 | 000 |
| 07290018915004 | K220771 | 000 |