Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)— 510(k) K242564

Name: FDA 510(k) clearance K242564
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K242564 for Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit), Substantially Equivalent on 2025-03-21. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2024-08-28
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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