Prostyle Compact
510(k) K961420
Prostyle Compact is a Class I device made by Planmeca Oy, cleared under FDA 510(k) K961420 on 10 Sep 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 | NumberK961420 | Date10 Sep 1996 | StatusActive |
Official records
- FDA 510(k) database K961420
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- Withdrawn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
Devices cleared under K961420
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Planmeca Compact i | 10031950, 10031951, 10031952, 10031953, 10039745, 10031954, 10031955 / i | 06430035420438 | — | On the market |
| Planmeca Compact i3 | 30021331, 30021332 / i3 | 06430035420612 | — | On the market |
| Planmeca Compact i5 | 30013450, 30015629, 30015630, 30015632, 30015633 / i5 | 06430035420575 | — | On the market |
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