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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K242564
Device Name Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Applicant Contact Haiyan Wei
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Correspondent Contact Haiyan Wei
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/28/2024
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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