Kingscross PL-C+B-10, PL-C+B-12, PL-C+B-08, B
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122039 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kingscross PL-C+B series is a dental handpiece designed for precision cutting and shaping of dental materials. These devices fall under the category of dental rotary instruments, used primarily in restorative and preparatory procedures such as cavity preparation, drilling, and finishing. Each model (PL-C+B-10, PL-C+B-12, PL-C+B-08, and B) is engineered for specific applications within dental practice, ensuring versatility in clinical workflows.
Supplied as reusable instruments, the Kingscross PL-C+B series is intended for use in dental offices and clinics. The devices are classified under FDA product code EBG (Dental Rotary Instruments) and hold a Traditional 510(k) clearance, affirming their substantial equivalence to a predicate device. Models are differentiated by size and functionality, with no indication of sterility requirements beyond standard dental instrument reprocessing protocols. No MRI safety information is provided, and storage should adhere to manufacturer guidelines for dental handpieces.
Frequently asked questions
What are the Kingscross PL-C+B handpieces used for in dental procedures?
The Kingscross PL-C+B series is designed for precision cutting and shaping in restorative and preparatory dental work. This includes cavity preparation, drilling, and finishing tasks, where accuracy and control are critical. Each model (PL-C+B-10, PL-C+B-12, PL-C+B-08, and B) is tailored to specific applications, ensuring adaptability for different clinical workflows.
Are the Kingscross PL-C+B handpieces single-use or reusable?
These handpieces are reusable instruments, intended for repeated use in dental offices and clinics. They follow standard dental instrument reprocessing protocols to maintain safety and functionality. No additional sterility requirements beyond typical dental practice guidelines are specified.
How do the different models (PL-C+B-10, PL-C+B-12, PL-C+B-08, B) differ?
The models are differentiated by size and functionality, which aligns them with specific clinical tasks. For example, the PL-C+B-10, PL-C+B-12, and PL-C+B-08 likely cater to varying degrees of precision or torque requirements, while the Kingscross B model may offer a distinct operational profile. The manufacturer’s design ensures each model meets unique procedural needs.
What regulatory clearance does the Kingscross PL-C+B series hold?
The Kingscross PL-C+B handpieces hold a Traditional 510(k) clearance from the FDA, classified under product code EBG (Dental Rotary Instruments). This clearance confirms their substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for dental rotary instruments.
How should the Kingscross PL-C+B handpieces be stored?
Storage should follow the manufacturer’s guidelines for dental handpieces to preserve functionality and hygiene. This typically includes keeping them in a clean, dry environment, protected from moisture and physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these can compromise performance and longevity.
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: Kingscross Pl-c+B-10, Kingscross Pl-c+B-12, Kingscross Pl-c+B-08 ..., Kingscross Pl-c+b-10, Kingscross Pl-c+b-12, Kingscross Pl-c+b-08 ..., fda.innolitics.com, api.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122039 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
Sources (1)
- FDA 510(k) K122039 24 fields · synced Oct 6, 2026