Pm 2002 Proline/Aec
by Planmeca Oy
510(k) K000163
Pm 2002 Proline/Aec is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K000163 on 18 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 | NumberK000163 | Date18 Apr 2000 | StatusActive |
Official records
- FDA 510(k) database K000163
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- Withdrawn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: MINIX-V / MINIX-S) by Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
- EzRay Air 2 Wall VEX-S350W by VATECH CO., LTD.
- ENDOS AC/ACP by VILLA SISTEMI MEDICALI S.P.A.