Planmeca Intracam Station
by Planmeca Oy
510(k) K984013
Planmeca Intracam Station is a Class I device made by Planmeca Oy, cleared under FDA 510(k) K984013 on 26 Jan 1999, 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 | NumberK984013 | Date26 Jan 1999 | StatusActive |
Official records
- FDA 510(k) database K984013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIA
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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