Modification to Digipan
by Trophy Radiologie 510(k)
Active
510(k) K991912
Overview
This device is a Unit, X-ray, Extraoral With Timer, classified under product code EHD and regulation number 872.1800. It is a modification to the Digipan system, intended for dental imaging applications.
The device was submitted by Trophy Radiologie and received FDA 510(k) clearance (K991912) on June 22, 1999, following a traditional review process. It is classified as a Class II medical device with special controls, and its manufacturing address is located in Marne La Vallee Cedex 2, France.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991912 | Date22 Jun 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EHD
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trophy Radiologie
Questions
What is the Modification to Digipan used for?
The Modification to Digipan is a Unit, X-ray, Extraoral With Timer, intended for dental imaging applications, as stated in its description and classification under product code EHD and regulation number 872.1800.
Who manufactures the Modification to Digipan and where is it made?
The device is manufactured by Trophy Radiologie, with its manufacturing address located in Marne La Vallee Cedex 2, France, as specified in the device data.
When did the Modification to Digipan receive FDA clearance and what was the submission number?
The device received FDA 510(k) clearance on June 22, 1999, under submission number K991912, following a traditional review process after being received on June 7, 1999.
What regulatory classification does the Modification to Digipan have?
The device is classified as a Class II medical device with special controls, under product code EHD and regulation number 872.1800, as indicated in its FDA 510(k) clearance details.