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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBF   EBG   PZY  
Date Received03/16/2022
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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