Pm 2002 Cc Proline
510(k) K970263
Pm 2002 Cc Proline is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K970263 on 26 Feb 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 | NumberK970263 | Date26 Feb 1997 | StatusActive |
Official records
- FDA 510(k) database K970263
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- Withdrawn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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