Identifiers
- 510(k) Number
- K991488 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)
Self Cure Composite is a dental restorative material designed for use in tooth restoration procedures. It is a Class II dental device with product code EBF, intended for applications in restorative dentistry as a filling material.
The device is supplied as a composite resin material for professional dental use. It is regulated under the FDA 510(k) premarket notification pathway and was cleared through the Traditional review pathway. The device is manufactured by Harry J. Bosworth Co. and is intended for single-use in dental procedures.
Frequently asked questions
What is Self Cure Composite used for?
Self Cure Composite is a dental restorative material used in tooth restoration procedures. It serves as a filling material in restorative dentistry, designed to repair or replace damaged tooth structure.
How is Self Cure Composite supplied?
It is supplied as a composite resin material intended for professional dental use. The product is packaged and distributed by Harry J. Bosworth Co. for use in clinical dental settings.
Is Self Cure Composite sterile?
The device data does not specify whether Self Cure Composite is supplied sterile. Dental composite resins are typically non-sterile unless otherwise indicated, and sterility would be confirmed only if explicitly stated in the product labeling.
Is Self Cure Composite single-use or reusable?
Self Cure Composite is intended for single-use in dental procedures. It is not designed for reuse, and each application should use a fresh portion of the material to ensure proper performance and hygiene.
What is the regulatory pathway for Self Cure Composite?
Self Cure Composite was cleared through the FDA 510(k) premarket notification pathway under the Traditional review process. It is classified as a Class II dental device with product code EBF and was determined to be substantially equivalent to existing devices.
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: K991488 FDA 510(k) - SELF CURE COMPOSITE | Harry J. Bosworth Co., SELF CURE COMPOSITE (K991488) — FDA 510 (k) | Innolitics, SELF CURE COMPOSITE 510 (k) K991488 - FDA.report, PDF K991488 SELF CURE COMPOSITE - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991488 | Class II | Active |
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Manufacturer
- Manufacturer
- Harry J. Bosworth Co.
Sources (1)
- FDA 510(k) K991488 24 fields · synced Oct 6, 2026