← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
DEVICE CLASS
Class II
REGULATION
21 CFR 880.6850
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES
Recent clearances
K253187Mastel Surgical · 510k2026-06-18
K260726Institut Straumann AG · 510k2026-06-03
K252854Case Medical, Inc. · 510k2026-06-03
K253791DePuy Mitek, Inc. · 510k2026-02-26
K251614Dentsply Sirona, Inc. · 510k2026-02-06
K251756Paragon Implant Mfg., LLC · 510k2025-11-14
K251300Dentsply Sirona, Inc. · 510k2025-07-22
K243425Talladium España, SL · 510k2025-07-22
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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