The following data is part of a premarket notification filed by Dmetec Co., Ltd. with the FDA for Cleanse S+ Ultrasonic Scaler.
| Device ID | K060171 |
| 510k Number | K060171 |
| Device Name: | CLEANSE S+ ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | DMETEC CO., LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula DMETEC CO., LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-23 |
| Decision Date | 2006-03-29 |
| Summary: | summary |