The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (no Light), Varios 550, Varios 150 Lux, Varios 150 (no Light).
| Device ID | K031421 |
| 510k Number | K031421 |
| Device Name: | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) |
| Classification | Scaler, Ultrasonic |
| Applicant | NAKANISHI, INC. 700B COOPER COURT Schaumburg, IL 60173 |
| Contact | Masayuki Onoguchi |
| Correspondent | Masayuki Onoguchi NAKANISHI, INC. 700B COOPER COURT Schaumburg, IL 60173 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-05 |
| Decision Date | 2004-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264562455 | K031421 | 000 |
| 04560264557710 | K031421 | 000 |
| 04560224984860 | K031421 | 000 |
| 04560224984570 | K031421 | 000 |
| 04560224984563 | K031421 | 000 |
| 04560224984549 | K031421 | 000 |
| 04560224984532 | K031421 | 000 |
| 04560224984266 | K031421 | 000 |
| 04560224979262 | K031421 | 000 |
| 04560264560024 | K031421 | 000 |
| 04560264560451 | K031421 | 000 |
| 04560264562448 | K031421 | 000 |
| 04560264562424 | K031421 | 000 |
| 04560264562417 | K031421 | 000 |
| 04560264560666 | K031421 | 000 |
| 04560264560659 | K031421 | 000 |
| 04560264560567 | K031421 | 000 |
| 04560264560536 | K031421 | 000 |
| 04560264560475 | K031421 | 000 |
| 04560224978913 | K031421 | 000 |