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

K242564 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.