Separating Medium (Polyvinyl Alcohol)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K896653 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Separating Medium (Polyvinyl Alcohol), classified under FDA product code EBF for dental applications. It is a water-soluble material designed to isolate and protect dental tissues during restorative procedures, such as cavity preparations, by preventing contamination from debris or moisture.
The separating medium is supplied as a single-use, non-sterile material intended for use in dental offices. It requires no special storage conditions beyond standard dental supply environments and is regulated under FDA 510(k) clearance (K896653) as substantially equivalent to prior-generation devices. No MRI safety or reusable specifications are indicated in the regulatory submission.
Frequently asked questions
What is the primary purpose of this separating medium in dental procedures, and how does it work?
This separating medium is designed to isolate and protect dental tissues during restorative work, such as cavity preparations. It’s made from water-soluble polyvinyl alcohol, which creates a barrier to block debris and moisture from contaminating the treatment area. This ensures a cleaner, drier workspace for accurate placement of restorative materials.
Is this separating medium sterile, and if not, what precautions should be taken during use?
No, this separating medium is not sterile—it is supplied as a non-sterile material for single-use in dental offices. Since it’s water-soluble and intended for direct contact with oral tissues, clinicians should follow standard aseptic techniques, such as using sterile instruments to handle it, and avoid reusing it to prevent cross-contamination.
How should this product be stored, and are there any special conditions required?
This separating medium requires no special storage conditions beyond typical dental supply environments. It can be kept in a dry, clean area away from extreme temperatures or humidity, as with other dental consumables. Since it’s single-use, ensure it’s stored in a sealed package until ready for use to maintain its integrity.
What regulatory pathway does this device follow, and what does that mean for dental professionals?
This separating medium is regulated under the FDA’s 510(k) clearance process (K896653) and is classified under product code EBF for dental applications. The clearance confirms it’s substantially equivalent to prior-generation devices, meaning it meets FDA standards for safety and effectiveness as intended for isolating dental tissues during restorative procedures. No additional approvals (like CE marking) are mentioned in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SEPARATING MEDIUM (POLYVINYL ALCOHOL) (K896653) — FDA 510(k) | Innolitics, 510(k) K896653 — SEPARATING MEDIUM (POLYVINYL ALCOHOL) - RegDataLab, SEPARATING MEDIUM (POLYVINYL ALCOHOL) 510(k) K896653 - FDA.report, PDF K896653 - Separating Medium (Polyvinyl Alcohol), US4078129A - Process for separating polyvinyl alcohol from its solution ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896653 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K896653 24 fields · synced Sep 18, 2026