Guided Surgery Kit Cases
by JJGC Indústria e Comércio de Materiais Dentários S/A.
510(k) K241492
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241492 | Date23 Aug 2024 | 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- Withdrawn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
- FDA applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- 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
The Guided Surgery Kit Cases are reusable rigid containers designed for the storage and organisation of surgical instruments and components used in dental implant procedures. These cases include a case bottom, a removable inner tray, and a lid, providing structured containment for guided surgery tools and related materials.
These containers are intended for use in dental clinics and surgical settings, offering a sterile and organised environment for implant surgery kits. Supplied as reusable items, they are not single-use and require proper cleaning and maintenance between uses. The device holds an FDA 510(k) clearance under the product code KCT, with no specific MRI safety or sterility classification noted in the data.
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Questions
AI-generated answers, 19 Sep 2026
Are these cases designed for single-use or can they be reused in a clinical setting?
These Guided Surgery Kit Cases are explicitly designed for reuse in dental clinics and surgical settings. Since they are reusable rigid containers, they require proper cleaning and maintenance between uses to ensure hygiene and functionality. The manufacturer emphasizes that they are not single-use items, so they must be disinfected and stored correctly to maintain a sterile environment for subsequent procedures.
What specific components do these cases include, and how do they contribute to dental implant procedures?
The Guided Surgery Kit Cases include a case bottom, a removable inner tray, and a lid, all of which work together to provide structured containment for surgical instruments and components used in dental implant procedures. The design ensures organized storage, making it easier to access tools while maintaining a sterile workspace during surgery.
How should these cases be stored when not in use, and are there any special considerations for their maintenance?
Since these cases are reusable, they must be cleaned and maintained properly between uses to prevent contamination and ensure longevity. While the data does not specify sterilization methods, standard clinical cleaning protocols (e.g., disinfection with appropriate agents) should be followed. Storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to preserve their structural integrity and hygiene.
What is the regulatory pathway for these cases, and how does the FDA classification apply to their use?
The Guided Surgery Kit Cases hold an FDA 510(k) clearance under product code KCT, classified as substantially equivalent to a predicate device. This means the FDA has determined they meet safety and effectiveness standards for their intended use in dental clinics and surgical settings. The clearance is based on a traditional review by the Orthopaedic and Rehabilitation Devices panel (HO), confirming compliance with regulatory requirements before clinical use.