Drilac Cubes and Granules
FDA PMAClass III (US FDA PMA)
by Osmed, Inc.
Identity
- Trade Name
- DRILAC CUBES{TM} FDA PMA
- Generic Name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID FDA PMA
Identifiers
- PMA Number
- P800012 FDA PMA
- FDA Product Code
- LPG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APWD FDA PMA
The Drilac Cubes and Granules are a surgical dressing composed of polylactic acid, classified as a Material, Dressing, Surgical, Polylactic Acid. This biodegradable material is designed for use in dental procedures to promote wound healing and tissue integration.
Supplied as either cubes or granules, Drilac is intended for single-use applications in surgical settings. The product is regulated under FDA Premarket Approval (PMA) with PMA number P800012 and falls under device class III. Sterility and packaging details are not specified in the provided data.
Frequently asked questions
What types of dental procedures is Drilac Cubes and Granules intended for, and how does it support healing?
Drilac Cubes and Granules are designed for use in dental surgical procedures to promote wound healing and tissue integration. The biodegradable polylactic acid material is intended to aid in the natural healing process by providing a scaffold-like structure that supports tissue regeneration. They are specifically classified under the FDA’s **Material, Dressing, Surgical, Polylactic Acid** category, meaning they are not a drug or implant but a surgical aid to assist in post-procedure recovery.
Are Drilac Cubes and Granules reusable, or are they meant for single-use only?
Drilac Cubes and Granules are explicitly supplied for **single-use applications** in surgical settings. This is a standard practice for biodegradable materials in medical procedures to ensure sterility and prevent cross-contamination between patients. Reuse is not recommended or supported by the manufacturer.
What forms does Drilac come in, and how does this affect its use in dental surgery?
Drilac is available in two forms: **cubes** and **granules**. The choice between these forms depends on the clinical need—cubes may be easier to handle in larger cavities or bone grafting, while granules can be more adaptable for filling smaller spaces or irregular surfaces. Both forms are designed to integrate with the surgical site to support healing, with the polylactic acid material gradually breaking down over time.
How was Drilac Cubes and Granules approved by the FDA, and what does this mean for its use in dental practices?
Drilac Cubes and Granules received **FDA Premarket Approval (PMA)** under PMA number **P800012**, classifying it as a **Class III device**. This means the FDA reviewed its safety and effectiveness through a rigorous process, including clinical trials, before approving it for dental surgical use. Clinicians can rely on this approval to ensure the product meets established standards for promoting wound healing and tissue integration in dental procedures.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P800012 | Class III | Active |
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Manufacturer
- Manufacturer
- Osmed, Inc.
Sources (1)
- FDA PMA P800012 24 fields · synced Sep 18, 2026