Planmeca ProMax ProMax 3D Plus
by Planmeca Oy
Planmeca ProMax ProMax 3D Plus (30016944) is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K103689 on 17 Mar 2011 and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 06430035420407), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06430035420407 | Date10 Aug 2016 | StatusListed |
| United States | FDA 510(k) | NumberK103689 | Date17 Mar 2011 | StatusActive |
Official records
- AccessGUDID record 06430035420407
- FDA 510(k) database K103689
Across registries
- FDA 510(k) K103689 decided 17 Mar 2011 Active
- FDA GUDID UDI-DI 06430035420407 listed 10 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K103689
- Listed FDA GUDID 06430035420407
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Planmeca ProMax
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / Ref / Catalog
- ProMax 3D Plus, 30016944
- Primary DI / UDI-DI
- 06430035420407
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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