FDA 510(k) clearance · back to tracker
Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)
Prismatik Dentalcraft, Inc. cleared K242564 on 2025-03-21, decision: substantially equivalent
K-number
K242564
Sponsor
Prismatik Dentalcraft, Inc.
Device
Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-03-21
Product code
KCT
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.6850
Official FDA record
Open K242564on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Raw record →
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.