Canal King (Thin) Canal King (Thick)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940368 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Canal King (Thin) and Canal King (Thick) are resin root canal filling instruments designed for endodontic treatment. These tools are used to prepare and shape the root canal system, ensuring proper cleaning and sealing during root canal therapy.
Supplied as single-use instruments, these devices are intended for use in dental offices and clinics. They are classified as Class II medical devices under FDA regulation 872.3820 and were granted 510(k) clearance in 1995. The Canal King (Thin) and Canal King (Thick) are non-sterile and must be sterilized prior to use. No MRI safety information is specified, and sizes are differentiated by thickness.
Frequently asked questions
Are the Canal King (Thin) and Canal King (Thick) instruments reusable or single-use, and what does that mean for sterilization?
The Canal King (Thin) and Canal King (Thick) are supplied as single-use instruments, meaning each device is intended for one patient treatment only. Since they are non-sterile as shipped, they must be sterilized prior to use in a dental office or clinic. This ensures proper infection control before shaping and cleaning root canals during endodontic procedures.
How do I determine which Canal King instrument to use based on the root canal’s size?
The Canal King instruments are differentiated by thickness, with the (Thin) and (Thick) variants designed for different canal diameters. The (Thin) version is intended for narrower canals, while the (Thick) version is suited for broader root canal systems. Always match the instrument thickness to the canal’s measured width for optimal shaping and sealing during root canal therapy.
What storage conditions should I follow for these instruments before sterilization?
Since the Canal King instruments are non-sterile and single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by keeping them in their original packaging until ready for sterilization. Follow your facility’s standard sterilization protocols (e.g., autoclave or chemical sterilization) before use to ensure safety and efficacy.
What is the primary purpose of these instruments in endodontic treatment?
The Canal King (Thin) and Canal King (Thick) are resin root canal filling instruments designed to prepare and shape the root canal system during endodontic therapy. Their purpose is to clean and seal the canal walls effectively, ensuring proper filling material placement for successful root canal treatment. They are not intended for diagnostic imaging or alternative procedures.
How were these instruments classified by the FDA, and what does that mean for my practice?
The Canal King instruments are classified as Class II medical devices under FDA regulation 872.3820, which means they undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a predicate device. This classification indicates they are subject to special controls (e.g., performance standards, labeling requirements) to ensure safety and effectiveness in dental offices and clinics. Their 510(k) clearance in 1995 confirms they meet FDA requirements for use in root canal preparation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CANAL KING (THIN) CANAL KING (THICK) (K940368) — FDA 510 (k) | Innolitics, CANAL KING (THIN) CANAL KING (THICK) (K940368) — FDA 510 (k) | Innolitics, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ..., Pulpdent Corp | Dispensing Products | Dental Supplies - tdsc.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940368 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K940368 24 fields · synced Sep 18, 2026