K242564
- 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. CA · US
- Product code
- KCT — Sterilization Wrap Containers, Trays, Cassettes & Ot
- Decision date
- 2025-03-21
- Date received
- 2024-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K242564.pdf
Official FDA record: K242564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.