The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ultrasonic Scaler.
| Device ID | K113717 |
| 510k Number | K113717 |
| Device Name: | ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2013-03-05 |
| Summary: | summary |