Cleared Traditional

Autoclavable Cassette (Glidewell HT? Implant Guided Surgical Kit, Glidewell HT? Implant Surgical Kit, Glidewell? Prosthetic Kit)

K242564 · Prismatik Dentalcraft, Inc. · General Hospital

Mar 2025

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K242564 is an FDA 510(k) clearance for the Autoclavable Cassette (Glidewell HT? Implant Guided Surgical Kit, Glidewell HT? Implant Surgical Kit, Glidewell? Prosthetic Kit), a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on March 21, 2025, 205 days after receiving the submission on August 28, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K242564 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2024
Decision Date	March 21, 2025
Days to Decision	205 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850