Panoramic X-Ray Unit (Modification)
by Planmeca Oy
510(k) K952763
Panoramic X-Ray Unit (Modification) is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K952763 on 7 Oct 1995, 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 | NumberK952763 | Date7 Oct 1995 | StatusActive |
Official records
- FDA 510(k) database K952763
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- Withdrawn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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- PORTABLE X-RAY SYSTEM (MODEL:EXARO, XRAY2GO) by OSSTEM IMPLANT CO.,LTD
- Orthophos E 6707488 by SIRONA Dental Systems GmbH