K242564

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

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.