Spacer No. GP3 Handle No. 30 0.35/30mm - Hu-Friedy - Delynov
The Spreader #GP3 manche #30 0,35/30mm - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Spreader #GP3 handle #30 0.35/30mm - Hu-Friedy?
The Spreader #GP3 from the Hu-Friedy brand is a manual instrument specifically designed for endodontic procedures. This device consists of a tapered working part and a #30 handle, offering a grip adapted to the requirements of dental surgery. Its structure is optimized for the lateral condensation of filling materials, such as gutta-percha. Manufactured by Hu-Friedy Mfg. Co., LLC, this instrument meets the quality standards of a recognized manufacturer in the field of surgical and endodontic instrumentation.
What are the clinical indications for this instrument?
The Spreader #GP3 is primarily indicated during the root canal obturation phases in endodontics. Its clinical role is to laterally compact gutta-percha cones against the root canal walls after biomechanical preparation. By creating a regular space for accessory cones, it allows for a dense and hermetic three-dimensional obturation. This instrument is used by dental surgeons and endodontic specialists to prevent apical reinfections by guaranteeing maximum sealing of the canal network.
What are the technical characteristics of the Spreader #GP3?
This Hu-Friedy instrument features precise technical dimensions with a 0.35mm diameter tip and a length of 30mm. These specifications allow for deep and controlled penetration, even in narrow or curved root canals. The #30 handle is designed to provide adequate balance during condensation maneuvers. As a Class I device, it is designed for repeated use after sterilization, respecting the rigorous hygiene protocols of dental practices and oral surgery clinics.
What are the contraindications for the use of this device?
According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for qualified healthcare professionals. Contraindications include use in clinical situations where the root anatomy does not allow the passage of a 0.35/30mm instrument without risk of fracture or perforation. Although the raw MDR text mentions the existence of indications and contraindications, it is necessary to systematically refer to the instructions for use provided by the manufacturer to identify any potential allergy to the components of the device.
What are the precautions for use and maintenance?
As the Spreader #GP3 is a non-resorbable instrument intended for repeated clinical use, it requires a strict cleaning, disinfection, and sterilization protocol between each patient. The practitioner must inspect the integrity of the 0.35/30mm tip before each intervention to detect any signs of wear or twisting. Excessive or inappropriate handling during lateral condensation can lead to mechanical stress on the instrument or the root structure. It is imperative to read the instructions carefully before use to ensure patient safety and the longevity of the instrument.
Who is the manufacturer and what standards are met?
The Spreader #GP3 is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I according to current regulations. The manufacturer Hu-Friedy is globally recognized for its expertise in the production of high-precision surgical instruments. As a Class I product, it meets the safety and performance requirements defined for this category of medical devices. Healthcare professionals must comply with the manufacturer's instructions to ensure use in accordance with regulatory standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
| Tags | |
|---|---|
| Tags | |