The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Prophy-mate Motor Handpiece, Models Prophy-mate (2000 Rpm Max), Endo-mate (600rpm Max.).
| Device ID | K990682 |
| 510k Number | K990682 |
| Device Name: | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-03 |
| Decision Date | 1999-03-24 |