Dental Dam Clamps Set - Hu-Friedy - Delynov
The Jeu crampons à digue - 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 rubber dam clamp set - Hu-Friedy - Delynov?
The rubber dam clamp set - Hu-Friedy - Delynov is a collection of specialized instruments designed for the placement and maintenance of the rubber dam during conservative and endodontic care. Manufactured by Hu-Friedy Mfg. Co., LLC, this Class I medical device is specifically developed to meet the requirements of oral surgery and modern dentistry. The structure of these clamps allows for precise adaptation to different dental morphologies, thus guaranteeing optimal stability of the operating field. As a central element of the rubber dam clamp kit, this set of instruments facilitates the isolation of the intervention area, thereby protecting soft tissues and preventing any contamination by saliva or blood during clinical procedures.
What are the clinical indications?
The clinical indications for this Hu-Friedy clamp set primarily concern the isolation of the operating field in dentistry and oral surgery. The use of this device is recommended during endodontic treatments to prevent the ingestion of instruments or irrigation solutions, as well as during adhesive restorations where the absence of moisture is critical for the durability of the care. The manufacturer Hu-Friedy specifies that the use of these instruments is strictly reserved for qualified healthcare professionals. The application of the rubber dam clamp kit effectively retracts gingival tissues and cheeks, offering increased visibility of the dental structures to be treated, while maintaining the rigorous asepsis essential for therapeutic success.
What are the technical characteristics?
Technically, the rubber dam clamp set from Hu-Friedy is distinguished by a rigorous design adapted to the constraints of the oral cavity. Although the specific materials are not detailed in the MDR technical sheet, the manufacturer Hu-Friedy Mfg. Co., LLC applies high manufacturing standards to guarantee the functionality of each piece of the rubber dam clamp kit. These instruments are classified as Class I medical devices, which attests to their compliance with basic regulatory requirements for non-invasive or low-invasive instrumentation. The geometry of each clamp is designed to offer adequate retention force without compromising the integrity of the enamel or the dental structure during placement.
What are the contraindications for use?
The contraindications and warnings provided by the manufacturer Hu-Friedy mention that the use of this device is exclusively reserved for healthcare professionals. Although specific clinical contraindications related to materials are not explicitly listed in the raw MDR documentation, the practitioner must systematically refer to the instructions for use before any intervention. Generally, the use of clamps may be contraindicated in patients presenting severe dental mobility or dental structures that are too decayed to allow for a secure grip of the clamp. It is imperative to check the condition of each instrument before use to ensure the absence of metal fatigue or deformation.
How is maintenance performed and what are the precautions?
As these are non-resorbable Class I instruments, the precautions for use are based on careful handling and rigorous maintenance. The manufacturer Hu-Friedy recommends a careful reading of the instructions for cleaning and sterilization protocols. Like any metallic instrument used in a clinical setting, the rubber dam clamp kit must be decontaminated, cleaned, and sterilized after each use to prevent any risk of cross-contamination. The practitioner must be careful not to exert excessive tension when opening the clamps with the clamp-holding forceps to preserve the elasticity of the metal. Regular visual inspection is necessary to identify any signs of wear or corrosion that could compromise patient safety during care.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This product is listed in the consumables category (CONSO) and benefits from a Class I regulatory classification. Hu-Friedy is a recognized manufacturer in the field of dental instrumentation, guaranteeing that the rubber dam clamp kit meets the quality and safety standards in force for medical devices. Although specific CE marking is not mentioned in the source data, compliance with Class I directives requires the manufacturer to respect controlled manufacturing processes. Healthcare professionals must imperatively consult the attached instructions for use to ensure compliance with the protocols recommended by Hu-Friedy.
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Specifications
| Manufacturer | Hu-Friedy |
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