Chrysalis Intelligence · Product Codes · KCT

KCT · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

General Hospital · 77 clearances · 48 unique sponsors

Device class
Class II
Regulation 880.6850
Total clearances
77
2020-03-06 → 2026-06-18
Last 12 months
6
Unique sponsors
48
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.6850
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Dentsply Sirona 5 1 2026-02-06
S.I.N. - Sistema DE Implante Nacional S.A. 4 0 2024-07-12
Aesculap, Inc. 4 0 2025-05-13
Case Medical 4 1 2026-06-03
K1 Medical, LLC 3 0 2021-12-28
Karl Storz Endoscopy America, Inc. 3 0 2021-07-06
JJGC Indústria e Comércio de Materiais Dentários S.A. 3 0 2024-08-23
Jjgc Industria E Comercio DE Materiais Dentarios S.A. 3 0 2023-04-20
THINK Surgical, Inc. 2 0 2021-12-20
Nobel Biocare Services AG 2 0 2023-06-27
Sweden & Martina S.P.A. 2 0 2023-05-26
Crossroads Extremity Systems, LLC 2 0 2024-07-16
Anthogyr 2 0 2023-12-22
Implant Direct Sybron Manufacturing, LLC 2 0 2021-01-28
Avinent Implant System S.L.U. 2 0 2021-03-01
Neotract, Inc. 2 0 2021-10-22
Stryker Instruments 1 0 2025-01-16
S.I.N. – Sistema DE Implante Nacional S.A. 1 0 2022-10-27
Richard Wolf Medical Instruments Corporation 1 0 2024-06-03
Paragon Implant Mfg., LLC 1 1 2025-11-14
Synthes GmbH 1 0 2025-03-28
Talladium España, SL 1 0 2025-07-22
Innovative Sterilization Technologies 1 0 2025-05-01
Infinitum Eta, Ltd. 1 0 2025-02-11
SOADCO, S.L. 1 0 2024-12-18
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4649 HCPCS Surgical supply; miscellaneous ✓ CMS-verified description High HCPCS code for surgical supplies including sterilization wraps and containers
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-18 K253187 Mastel Surgical SteriBest® Sterilization Tray System
2026-06-03 K260726 Institut Straumann AG Straumann® ProClean™ Cassette (041.800 ; 041.801)
2026-06-03 K252854 Case Medical, Inc. SteriTite Container System with MediTray Products
2026-02-26 K253791 DePuy Mitek, Inc. PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid
2026-02-06 K251614 Dentsply Sirona, Inc. Stainless Steel Surgical Kits
2025-11-14 K251756 Paragon Implant Mfg., LLC Sterilization Trays
2025-07-22 K251300 Dentsply Sirona, Inc. Plastic Surgical Kits
2025-07-22 K243425 Talladium España, SL Guided DAS Surgical Kit
2025-06-20 K243589 Microaire Surgical Instruments, LLC PAL Sterilization Case
2025-05-13 K242762 Aesculap, Inc. Aesculap Aicon® Series Container System
2025-05-01 K250029 Innovative Sterilization Technologies ONE TRAY® Sealed Sterilization Container System
2025-03-28 K241927 Synthes GmbH Synthes Graphic Case & Tray System
2025-03-21 K242564 Prismatik Dentalcraft, Inc. Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
2025-02-19 K242023 Implant Microdent System S.L.U. Microdent Sterilization Cassette
2025-02-11 K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray
2025-01-16 K242834 Stryker Instruments System 9 Sterile Battery Container
2024-12-18 K243128 SOADCO, S.L. Klockner Kits
2024-08-23 K241492 JJGC Indústria e Comércio de Materiais Dentários S.A. Guided Surgery Kit Cases
2024-07-31 K240898 Case Medical SteriTite rigid reusable sterilization container with MediTray Products
2024-07-16 K241050 Crossroads Extremity Systems CrossRoads Modular Tray System
2024-07-12 K241378 S.I.N. - Sistema DE Implante Nacional S.A. S.I.N. Instrument Kits
2024-06-03 K231291 Richard Wolf Medical Instruments Corporation Perforated Baskets
2024-03-22 K233578 Bahadir USA, LLC BAHADIR STERILIZATION CONTAINERS
2024-01-16 K231144 Dentsply Sirona Washtrays
2023-12-22 K233264 Anthogyr Anthogyr INTEGRAL Guided Surgery Cassettes