Dixi 2
by Planmeca Oy
510(k) K000428
Dixi 2 is a medical device (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by Planmeca Oy, cleared under FDA 510(k) K000428 on 28 Apr 2000, 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 | FDA 510(k)SESE | NumberK000428 | Date28 Apr 2000 | StatusActive |
Official records
- FDA 510(k) database K000428
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
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