Planmeca Intracam
by Planmeca Oy
510(k) K972033
Planmeca Intracam is a Class I device made by Planmeca Oy, cleared under FDA 510(k) K972033 on 20 Jun 1997, 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 | NumberK972033 | Date20 Jun 1997 | StatusActive |
Official records
- FDA 510(k) database K972033
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- Withdrawn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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