Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
|
510(k) Number |
K220771 |
Device Name |
Stratasys TrueDent |
Applicant |
Stratasys Ltd |
1 Holtzman St. Science Park |
P.O. Box 2496 |
Rehovot,
IL
7612401
|
|
Applicant Contact |
Melanie Glennon |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 872.3760
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/16/2022 |
Decision Date | 07/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|