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Sign in to claim this brandWhat ACTEON MANUFACTURING makes
The company produces gingival retraction kits, including disposable and reusable variants designed to isolate gum tissue during dental procedures. These kits come in multiple sizes and flavors, such as strawberry, to accommodate different clinical needs and patient preferences.
The portfolio consists of Class II (U) devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Acteon Manufacturing produce?
Acteon Manufacturing specializes in gingival retraction kits, which are used in dental procedures to isolate gum tissue. These kits come in disposable and reusable forms, with variations like different sizes and flavors (such as strawberry) to suit clinical and patient needs.
Where is Acteon Manufacturing based?
Acteon Manufacturing is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as its devices are designed and manufactured there.
How are Acteon Manufacturing’s devices classified under medical regulations?
Acteon Manufacturing’s devices fall under Class II (U) classification, which is the standard for many dental instruments and accessories in the U.S. This classification means they undergo specific regulatory controls to ensure safety and effectiveness before being listed.
Are Acteon Manufacturing’s devices listed in any regulatory registries?
Yes, Acteon Manufacturing’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- acteongroup.com
- —
- —
- [email protected]
- Phone
- +33(0)556349292
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 283473691
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acteon | BIOSPLINT RIBBON | FDA UDI | Class II | Unknown |
| Acteon | Hemostasyl Kit | FDA UDI | U | Unknown |
| EXPASYL x20 | EXPASYL | FDA UDI | U | Active |
| EXPASYL strawberry flavor | EXPASYL | FDA UDI | U | Active |
| Acteon | Hemostasyl syringes | FDA UDI | U | Unknown |
| EXPASYL x6 | EXPASYL | FDA UDI | U | Active |
| Acteon | EXPASYL EXACT | FDA UDI | U | Active |
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