Composite Material
by Adp Intl., Inc. 510(k)
Active
510(k) K760979
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760979 | Date15 Nov 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Composite Material, defined as a manufactured product composed of two or more distinct constituent materials with significantly different physical or chemical properties, bonded together to form a new material with improved characteristics. It falls under the Dental category and is classified as a dental restorative material, typically used for filling cavities or repairing teeth. The material is designed to provide structural integrity and durability while mimicking the appearance of natural tooth enamel.
The Composite Material is supplied as a dental filling substance and is intended for single-use applications in clinical settings. It is regulated under FDA 510(k) clearance (K760979) and is classified under product code EBF (Dental Restorative Materials). The device is not sterile at the point of sale but is intended to be used in a controlled clinical environment where proper sterilization protocols are followed. No additional regulatory status beyond the provided FDA clearance is stated.
Other devices from Adp Intl., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Adp Composite Material used for in dental procedures?
The Adp Composite Material is designed as a dental restorative substance for filling cavities or repairing damaged teeth. It combines multiple materials to create a durable filling that closely resembles natural tooth enamel in both structure and appearance, ensuring both functionality and aesthetics for patients.
Is the Adp Composite Material sterile when purchased?
No, the Adp Composite Material is not sterile at the point of sale. It is intended for use in a clinical environment where proper sterilization protocols are followed before application. This ensures a controlled and safe setting for dental procedures.
How is the Adp Composite Material supplied, and is it single-use?
The Adp Composite Material is supplied as a dental filling substance and is intended for single-use applications. This design minimizes cross-contamination risks and ensures each patient receives a fresh, uncontaminated material during their procedure.
What regulatory approval does the Adp Composite Material hold?
The Adp Composite Material holds FDA 510(k) clearance under the reference number K760979. It is classified under product code EBF (Dental Restorative Materials) and is considered substantially equivalent to legally marketed predecessors, as determined by the FDA.
Can this composite material be reused after initial use?
No, the Adp Composite Material is explicitly designed for single-use only. Reusing dental restorative materials can introduce contamination risks, compromise patient safety, and violate clinical best practices. Always follow the manufacturer’s guidelines for proper disposal after use.