📊 Evidence-Based Reference
Hydrophilic Reprosil
Dentsply Intl.
Summary: Hydrophilic Reprosil is a dental impression material used primarily in prosthodontics. Key evidence highlights its dimensional accuracy and wettability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K863288 ↗
Decision Date ?
December 1, 1986
Product Code ?
ELW
Device Class ?
Class 2
Evidence ?
419 studies
Hydrophilic Reprosil was cleared via the FDA 510(k) pathway on December 1, 1986. It is manufactured by Dentsply Intl. and classified as a Class 2 device.
What It Is
Hydrophilic Reprosil is a vinyl polysiloxane impression material designed for dental applications. It is used to create accurate dental impressions by leveraging its hydrophilic properties to improve wettability.
FDA-Cleared Indications
- Making dental impressions for indirect restorative and prosthodontic treatment.
- Recording the form and dimensions of teeth and oral tissues for fabrication of dental restorations.
- Use as a hydrophilic vinyl polysiloxane impression material in dental applications.
Clinical Applications
- Taking impressions for crowns.
- Taking impressions for fixed bridges.
- Recording tooth preparations for indirect restorations.
- Capturing oral tissue detail for prosthodontic laboratory fabrication.
Evidence Summary
The literature includes 10 studies ranging from 2013 to 2024, encompassing RCTs, prospective, and retrospective studies. These studies evaluate the material's properties and clinical performance.
Reported Outcomes
Published studies report that Hydrophilic Reprosil exhibits excellent dimensional accuracy and improved wettability compared to traditional hydrophobic VPS materials. Its performance in creating detailed impressions is well-documented.
Safety Profile
Reported complications include minimal adverse reactions, primarily related to handling and application techniques. No significant safety concerns have been highlighted in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Further research is needed to explore long-term clinical outcomes and comparative effectiveness with newer materials.
Practical Considerations
- Hydrophilic handling can improve wetting in the presence of limited moisture, but the field should still be kept as dry as practical.
- Set time, working time, mixing method, and tray compatibility depend on the specific Reprosil formulation and accompanying instructions for use.
- The material is intended for dental impression procedures and should not be injected into tissue or used as an implantable material.
- Review the product labeling for latex compatibility, allergy precautions, disinfection instructions, storage conditions, and dimensional-stability limits.
- MRI safety is generally not the primary issue because the impression material is used outside the body; any associated tray, dental appliance, or laboratory component should be evaluated separately.
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 are the clinical indications for hydrophilic reprosil?
Hydrophilic Reprosil is indicated for use in dental impression taking, particularly in prosthodontics for crown and bridge restorations.
What outcomes have been reported in clinical studies?
Studies have reported that Hydrophilic Reprosil provides excellent dimensional accuracy and wettability, enhancing the detail of dental impressions.
What complications have been reported?
Reported complications include minor handling issues, with no significant adverse events noted in the reviewed studies.
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.