Identifiers
- 510(k) Number
- K872890 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)
Synergy is a dental device classified under the product code EBF, intended for use in dental procedures. It is designed to assist in the preparation and application of dental materials, ensuring precise and efficient handling during restorative or prosthetic treatments.
The Synergy device is supplied by Scientific Pharmaceuticals, Inc., and holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of August 3, 1987. It is intended for single-use or reusable applications in clinical dental settings, adhering to regulatory standards for dental instruments. No additional sterility or MRI safety information is provided in the specifications.
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: Synergy Pharmaceuticals | Empowering Healthcare Through Innovation, Synergy Pharmaceuticals, Synergy Pharmaceuticals Inc. - Streetwise Reports, PDF Company Fact Sheet: Synergy Pharmaceuticals
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872890 | Class II | Active |
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Manufacturer
- Manufacturer
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA 510(k) K872890 24 fields · synced Oct 1, 2026