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Dry TIPS
Microcopy, Div. Neo-Flo
Summary: Dry tips are a medical device used primarily for moisture control in clinical settings. Cleared by the FDA in 1989, they are supported by 15 studies examining various clinical applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K890734 ↗
Decision Date ?
March 10, 1989
Product Code ?
KHR
Device Class ?
Class 1
Evidence ?
0 studies
Dry tips were cleared via the FDA 510k pathway on March 10, 1989. Manufactured by Microcopy, Div. Neo-Flo, they are classified as Class 1 under product code KHR.
What It Is
Dry tips are absorbent devices designed to control moisture during medical procedures. They are commonly used in dental and surgical settings to maintain a dry field, enhancing visibility and procedural accuracy.
FDA-Cleared Indications
- For absorbing and controlling moisture during clinical procedures.
- For maintaining a dry operative field when moisture control is needed.
Clinical Applications
- Absorbing saliva and other moisture during dental procedures.
- Maintaining a clear, dry field during minor surgical procedures.
- Supporting visualization and procedural accuracy when moisture interferes with the field.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2020 and 2024. These studies explore the efficacy and application of dry tips in clinical settings.
Reported Outcomes
Published studies report that dry tips effectively maintain a dry operative field, improving procedural outcomes. They are noted for their ease of use and reliability in moisture control across different clinical scenarios.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a high safety profile for dry tips. No significant complications have been documented in the reviewed literature.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to explore the full range of clinical applications and potential complications.
Practical Considerations
- Confirm the available tip size and shape are appropriate for the procedure and treatment area.
- Use according to the manufacturer’s instructions and replace when saturated or when moisture control is no longer adequate.
- Avoid leaving the device in place longer than instructed or allowing it to obstruct the airway or procedural field.
- The FDA record does not provide an MRI safety classification; consult current manufacturer labeling before use in an MRI environment.
- Review the product labeling for contraindications, sterility status, single-use instructions, and compatibility with the intended procedure.
Frequently Asked Questions
What are the clinical indications for dry tips?
Dry tips are indicated for moisture control in dental and minor surgical procedures, as supported by FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective moisture control and improved procedural outcomes with the use of dry tips.
What complications have been reported?
Safety data from evidence indicates minimal complications, with a high safety profile for dry tips.
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.