Planmeca ProMax with Dynamic Exposure Control
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Planmeca Oy
Identifiers
- 510(k) Number
- K051464 FDA 510(k)
- FDA Product Code
- EHD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Planmeca ProMax with Dynamic Exposure Control is an extraoral X-ray imaging system designed for dental radiographic examinations. It captures panoramic and cephalometric images of the teeth, jaw, and oral structures, enabling diagnostic assessment of dental and maxillofacial conditions.
This device is supplied as a reusable medical instrument, intended for use in dental clinics and oral healthcare settings. It operates with dynamic exposure control to optimize image quality while minimizing radiation dose, and is classified as a Class II device under FDA regulations. The system may be equipped with additional accessories to support specialized diagnostic needs.
Frequently asked questions
What is the Planmeca ProMax with Dynamic Exposure Control used for?
The Planmeca ProMax with Dynamic Exposure Control is an extraoral X-ray imaging system designed for dental radiographic examinations, capturing panoramic and cephalometric images of the teeth, jaw, and oral structures to enable diagnostic assessment of dental and maxillofacial conditions.
Is the Planmeca ProMax with Dynamic Exposure Control a single-use or reusable device?
The Planmeca ProMax with Dynamic Exposure Control is supplied as a reusable medical instrument intended for use in dental clinics and oral healthcare settings.
What regulatory approvals does the Planmeca ProMax with Dynamic Exposure Control have?
The Planmeca ProMax with Dynamic Exposure Control has FDA 510(k) clearance, MDD approval, and MDR approval, and is classified as a Class II device under FDA regulations.
How does the Dynamic Exposure Control feature work?
The Dynamic Exposure Control feature optimizes image quality while minimizing radiation dose during dental radiographic examinations.
What accessories can be used with the Planmeca ProMax with Dynamic Exposure Control?
The system may be equipped with additional accessories to support specialized diagnostic needs, though specific accessories are not detailed in the provided information.
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: Planmeca ProMax 2D panoramic dental imaging units, Planmeca Promax With Dec (Dynamic Exposure Control) (K051464) — Fda 510 ..., Planmeca Promax With Dec (dynamic Exposure Control) 510 (k) FDA ..., PDF Planmeca ProMax 2D S3 panoramic X-ray unit
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K051464 | Class II | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (2)
- FDA 510(k) K051464 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026