Planmeca ProMax
Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the…
Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shanghai Handy Medical Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Planmeca Oy, Finland |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Manufacturer |
| 510(k) | K051464 |
| Record published | 2016-09-19 |
| Record revised | 2025-09-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-08-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ProMax 2D | In distribution | |
| ProMax 3D | In distribution | |
| ProMax 3D Mid | In distribution | |
| ProMax 3D | In distribution | |
| ProMax 2D | In distribution | |
| ProMax 3D Plus | In distribution | |
| ProMax 3D Plus | In distribution | |
| ProMax 3D Mid | In distribution | |
| ProMax 2D | Withdrawn | |
| ProMax 3D | Withdrawn | |
| ProMax 3D | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick Elite | Sirona Dental, Inc. | 38 |
| Schick Wifi | Sirona Dental, Inc. | 31 |
| Midmark Intraoral Digital Sensor | Midmark Corporation | 26 |
| Xios XG Wifi | Sirona Dental, Inc. | 25 |
| Midmark OptiMax Digital Sensor System | Midmark Corporation | 24 |
| Gendex GXS-700™ intraoral sensor | Gendex Corp. | 19 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | DE Götzen SRL | 12 |
| X-Mind optima 3D | DE Götzen SRL | 12 |
| Dexis Titanium Sensor Kit | Dental Imaging Technologies Corporation | 11 |
| Xios XG Select | Sirona Dental, Inc. | 11 |
| CDR Elite | Sirona Dental, Inc. | 11 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103689 | 2011-03-17 |
| K093590 | 2010-05-12 |
| K072244 | 2007-09-21 |
| K060328 | 2006-03-15 |
| K000454 | 2000-03-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.