The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Spaceline Feel 21.
| Device ID | K953865 |
| 510k Number | K953865 |
| Device Name: | SPACELINE FEEL 21 |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1996-03-20 |