Dental, Medical Instrument Cases & Cassette
by Sterilization Cassette Systems, Inc.
510(k) K962545
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962545 | Date7 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KCT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Dental, Medical Instrument Cassettes and Cases designed for the storage and transport of dental and medical instruments. It provides a structured, organized system to hold instruments securely during sterilization and processing, ensuring proper exposure to sterilization agents while maintaining sterility and preventing cross-contamination.
The cassettes are intended for use in dental and medical settings, including general hospital environments, and are supplied as reusable components. They are not sterile upon receipt but are engineered for repeated use after proper cleaning and sterilization. The product is authorized under FDA 510K clearance (K962545) and adheres to traditional review standards. Storage and handling should follow manufacturer guidelines to maintain functionality and compliance with regulatory requirements.
Questions
AI-generated answers, 19 Sep 2026
Are these instrument cases designed for single-use or can they be reused after proper cleaning and sterilization?
These cases are reusable and engineered for repeated use in dental and medical settings. They are not sterile upon receipt, so they must be cleaned and sterilized between uses to maintain functionality and prevent cross-contamination. Following the manufacturer’s guidelines for sterilization and handling is essential to ensure compliance and longevity.
What types of environments or facilities are these cassettes intended for, and how do they help with sterilization?
These cassettes are designed for dental and medical settings, including general hospital environments. They provide a structured system to securely hold instruments during sterilization, ensuring proper exposure to sterilization agents while preventing damage or misplacement. Their organized design helps maintain sterility and streamline processing workflows.
How should these cases be stored when not in use, and are there any special handling instructions?
Storage should follow the manufacturer’s guidelines to maintain functionality and compliance. While the data does not specify exact storage conditions, reusable medical instrument cases typically require protection from moisture, extreme temperatures, and physical damage. Proper cleaning and periodic inspections are also recommended to ensure they remain effective for repeated use.
What is the regulatory pathway for this product, and how was its equivalence determined?
This product was cleared via the FDA 510(k) pathway under clearance number K962545, with a decision of Substantially Equivalent (SESE). The review was conducted under traditional standards by the General Hospital (HO) Advisory Committee, confirming its compliance with regulatory requirements for dental and medical instrument storage and transport.