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rhodia hydrophilic dental impression material
Rhodia
Summary: The Rhodia Hydrophilic Dental Impression Material is used by dental professionals to create precise dental impressions. It is particularly useful in capturing detailed impressions for prosthodontic and orthodontic applications.
FDA Clearance Information
Pathway
510K
Number
K013140 ↗
Decision Date
October 10, 2001
Product Code
ELW
Device Class
Class 2
Evidence
419 studies
The Rhodia Hydrophilic Dental Impression Material was cleared through the FDA 510(k) pathway on October 10, 2001. Manufactured by Rhodia, it is classified as a Class 2 medical device under product code ELW.
What It Is
The Rhodia Hydrophilic Dental Impression Material is a dental tool used to capture accurate impressions of teeth and gums. Its hydrophilic properties allow it to perform well in moist conditions, ensuring detailed and precise impressions. This material is essential for creating molds that are used in the fabrication of dental prosthetics, such as crowns, bridges, and dentures.
Clinical Applications
This impression material is commonly used in prosthodontics and orthodontics to create molds for crowns, bridges, and aligners. It is particularly beneficial in situations where precision is critical, such as in the fitting of dental prosthetics. Dental clinics and laboratories frequently use this material to ensure high-quality outcomes for patients requiring restorative dental work.
Indications for Use
The FDA indications suggest this material is intended for use in capturing dental impressions, particularly in patients requiring restorative or corrective dental procedures. It is suitable for a wide range of dental conditions where accurate impressions are necessary.
Practical Considerations
The material is typically available in various viscosities to suit different clinical needs. It is compatible with standard impression trays and requires careful handling to ensure optimal results. Clinicians should be familiar with the setting times and handling characteristics to maximize the material's effectiveness.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Rhodia Hydrophilic Dental Impression Material used for?
It is used to create precise dental impressions for prosthodontic and orthodontic applications.
What specialties typically use this device?
Prosthodontics and orthodontics are the primary specialties that use this impression material.
What are the FDA-cleared indications?
It is indicated for capturing dental impressions, particularly for restorative and corrective dental procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.