Prostyle Compact
510(k) K963209
Prostyle Compact is a Class I device made by Planmeca Oy, cleared under FDA 510(k) K963209 on 24 Oct 1996, 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 | NumberK963209 | Date24 Oct 1996 | StatusActive |
Official records
- FDA 510(k) database K963209
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLC
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6250
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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