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510(k) K242564

Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) by Prismatik Dentalcraft, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
August 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
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