Recharge for Crown Lengthening Gauge PAPILLA - Hu-Friedy - Delynov
The Recharge pour jauge allongement de couronne PAPILLA - 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 refill for the Hu-Friedy PAPILLA crown lengthening gauge?
The refill for the PAPILLA crown lengthening gauge, designed by the manufacturer Hu-Friedy Mfg. Co., LLC, is a specific component intended to complete the measurement instrumentation in periodontal surgery. This device integrates into the PAPILLA system, recognized for its utility in evaluating biological dimensions during pre-prosthetic phases. As a technical consumable, this refill allows the practitioner to maintain the integrity and precision of their surgical diagnostic kit. It is developed according to Hu-Friedy quality standards, guaranteeing perfect compatibility with the original instruments of the range for reliable chairside handling.
What are the clinical indications for this device?
This device is primarily indicated during oral surgery interventions aimed at clinical crown lengthening. It is used by periodontists and implantologists to precisely measure the distance between the cemento-enamel junction or the future preparation limit and the alveolar bone crest. Using the Hu-Friedy PAPILLA gauge is crucial for planning the osteotomy and osteoplasty necessary to restore a healthy biological width. It helps prevent post-prosthetic complications such as chronic gingival inflammation or uncontrolled tissue recession by providing clear visual markers during the surgical act.
What are the technical characteristics of this refill?
The PAPILLA gauge refill is specifically calibrated to fit Hu-Friedy brand handles and supports. Although detailed material specifications are not explicitly listed in the source data, this product belongs to the Class I consumable category. Its design is optimized to offer maximum readability during intra-oral measurements, allowing for a rigorous evaluation of soft and hard tissues. The precision machining by Hu-Friedy Mfg. Co., LLC ensures that each refill meets the strict requirements of periodontal and implant surgery protocols, thus facilitating the precision work of the dental surgeon.
What are the contraindications for the use of this product?
According to the information provided by the manufacturer Hu-Friedy, the use of this device is strictly reserved for qualified healthcare professionals. There are no specific medical contraindications mentioned in the raw technical documentation, other than those generally related to periodontal surgery interventions. The practitioner must, however, ensure the absence of known allergies to components of standard surgical instrumentation. As with any Class I medical device, a prior clinical evaluation of the patient's health status and the feasibility of crown lengthening is imperative before any use.
What are the precautions for use and maintenance?
As a Class I device used in a surgical environment, it is imperative to carefully read the instructions for use provided by Hu-Friedy before any handling. Although the product is classified as a consumable (CONSO), compliance with current sterilization and disinfection protocols for dental instrumentation is necessary if the device is reusable or before its first placement in the mouth, in accordance with the manufacturer's instructions. The practitioner must ensure the integrity of the refill before use to guarantee the accuracy of the measurements. Any visible alteration of the gauge must lead to its immediate replacement so as not to distort the clinical diagnosis.
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, Illinois, USA. This product is listed under Class I according to current medical device regulations. The Hu-Friedy brand is recognized in the dental sector for its adherence to rigorous manufacturing standards. Although specific CE marking is not detailed in the current sources, compliance with safety and performance requirements for Class I devices is ensured by the American manufacturer's quality control processes. Professionals should refer to the labeling and instructions for any additional regulatory information.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Hu-Friedy |
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