K953865 is an FDA 510(k) clearance for the SPACELINE FEEL 21. This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on March 20, 1996, 216 days after receiving the submission on August 17, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K953865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1995 |
| Decision Date | March 20, 1996 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFA — Handpiece, Belt And/or Gear Driven, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |